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Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00360568
Recruitment Status : Completed
First Posted : August 4, 2006
Results First Posted : January 16, 2015
Last Update Posted : January 16, 2015
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Dyskinesias
Parkinson's Disease
Severe Motor Fluctuations
Interventions Drug: Levodopa-carbidopa intestinal gel
Device: CADD-Legacy® 1400 ambulatory infusion pump
Device: PEG tube
Device: J-tube
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)
Hide Arm/Group Description

All participants received levodopa-carbidopa intestinal gel (LCIG), delivered through a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J), administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

Period Title: Overall Study
Started 33 29
Completed 31 24
Not Completed 2 5
Reason Not Completed
Adverse Event             1             2
Lack of Efficacy             1             0
Withdrawal by Subject             0             3
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) Total
Hide Arm/Group Description

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

Total of all reporting groups
Overall Number of Baseline Participants 33 29 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 29 participants 62 participants
63.6  (9.0) 64.8  (6.6) 64.1  (7.9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
<65 years 19 13 32
>=65 years 14 16 30
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
Female
10
  30.3%
8
  27.6%
18
  29.0%
Male
23
  69.7%
21
  72.4%
44
  71.0%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
Hide Description AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.
Time Frame From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J, plus 30 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 29 62
Measure Type: Number
Unit of Measure: participants
Deaths 0 0 0
TE Deaths 0 0 0
>=1 SAE 5 9 14
>=1 TESAE 5 9 14
>=1 TEAE Leading to Study Termination 1 2 3
>=1 TEAE 31 28 59
>=1 Severe TEAE 5 10 15
>=1 Possibly or ProbablyTreatment-Related TEAE 28 20 48
No TEAEs 2 1 3
2.Primary Outcome
Title Number of Participants With Device Complications
Hide Description Complications of the infusion device were collected. Pump, intestinal tube, PEG, stoma, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and device site reaction.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 29 62
Measure Type: Number
Unit of Measure: participants
>=1 Complication 26 24 50
Pump Complication 18 16 34
Intestinal Tube Complication 15 16 31
PEG Complication 11 11 22
Stoma Complication 12 15 27
Other 6 4 10
3.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Values for Hematology Parameters
Hide Description Terms abbreviated in the table include females (f) and males (m).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had an assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 28 61
Measure Type: Number
Unit of Measure: participants
Red Blood Cells <2.0 10^12/L (f); <2.5 10^12/L (m) 0 0 0
Haemoglobin <90 g/L (f); <100 g/L (m) 0 1 1
Haematocrit <30% (f); <34% (m) 1 1 2
White Blood Cells <2.8 10^9/L 0 0 0
White Blood Cells >16.0 10^9/L 0 0 0
Neutrophils, Absolute <1.2 10^9/L 0 0 0
Lymphocytes >80% 0 0 0
Lymphocytes, Absolute <.75 10^9/L 2 0 2
Eosinophils >10% 0 0 0
Monocytes >30% 0 0 0
Platelet Count <95 10^9/L 0 0 0
Platelet Count >700 10^9/L 0 0 0
Mean Corpuscular Volume <60 fL 0 0 0
Mean Corpuscular Volume >120 fL 0 0 0
4.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters
Hide Description Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with an assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 29 62
Measure Type: Number
Unit of Measure: participants
Sodium <126 mmol/L; n=33, 28, 61 0 0 0
Sodium >156 mmol/L; n=33, 28, 61 0 0 0
Albumin <25 g/L; n=27, 20, 47 0 0 0
Albumin >70 g/L; n=27, 20, 47 0 0 0
Potassium <3.0 mmol/L; n=33, 28, 61 0 0 0
Potassium >6.0 mmol/L; n=33, 28, 61 0 0 0
Creatinine >177 µmol/L; n=33, 28, 61 0 0 0
Calcium <1.75 mmol/L; n=33, 28, 61 0 0 0
Calcium >3.0 mmol/L; n=33, 28, 61 0 0 0
Total Protein <45 g/L; n=33, 28, 61 0 0 0
Total Bilirubin >2xULN; n=33, 28, 61 0 0 0
Aspartate Aminotransferase >3xULN; n=33, 28, 61 0 0 0
Alanine Aminotransferase >3xULN; n=33, 28, 61 0 0 0
Gamma-glutamyl Transpeptidase >3x ULN;n=33, 28, 61 1 1 2
Lactate dehydrogenase >3x ULN; n=33, 28, 61 0 0 0
Alkaline Phosphatase >400 U/L; n=33, 28, 61 0 0 0
Creatine Phosphokinase >3x ULN; n=33, 28, 61 0 0 0
Non-fasting Glucose <2.78 mmol/L; n=33, 28, 61 0 0 0
Non-fasting Glucose >16.0 mmol/L; n=33, 28, 61 0 0 0
Uric Acid>500µmol/L(f);>590µmol/L(m);n=33, 28, 61 0 0 0
Blood Urea Nitrogen >10.8 mmol/L; n=28, 22, 50 3 0 3
Cholesterol >12.9 mmol/L; n=33, 28, 61 0 0 0
Triglycerides >5.6 mmol/L; n=33, 28, 61 0 0 0
5.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Vital Sign Parameters
Hide Description Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), and body temperature (Temp). Increase and decrease are signified by ↑ and ↓, respectively.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 29 62
Measure Type: Number
Unit of Measure: participants
SuSBP <=90 and >30 mm Hg ↓ from BL; n=33, 29, 62 3 0 3
SuSBP >=180 and >40 mm Hg ↑ from BL; n=33, 29, 62 1 2 3
StSBP <=90 and >30 mm Hg ↓ from BL; n=33, 29, 62 4 7 11
StSBP >=180 and >40 mm Hg ↑ from BL; n=33, 29, 62 0 0 0
OSBP: ↓ >=30 mm Hg Supine to Standing; n=33,29,62 8 11 19
SuDBP <=50 and >30 mm Hg ↓ from BL; n=33, 29, 62 0 1 1
SuDBP >=105 and >30 mm Hg ↑ from BL; n=33, 29, 62 1 1 2
StDBP <=50 and >30 mm Hg ↓ from BL; n=33, 29, 62 1 0 1
StDBP >=105 and >30 mm Hg ↑ from BL; (n=33,29,62) 2 1 3
ODBP: ↓ >=20 mm Hg Supine to Standing; n=33,29,62 7 7 14
SuP <=50 and >30 bpm ↓ from BL; n=33, 29, 62 1 0 1
SuP >=120 and >30 bpm ↑ from BL; n=33, 29, 62 0 0 0
StP <=50 and >30 bpm ↓ from BL; n=33, 29, 62 0 0 0
StP >=120 and >30 bpm ↑ from BL; n=33, 29, 62 0 1 1
Temp >=38.3° and >=1.1°C ↑ from BL; n=33, 29, 62 0 0 0
Weight <=7% ↓ from BL; n=33, 27, 60 5 5 10
Weight >=7% ↑ from BL; n=33, 27, 60 8 8 16
6.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters
Hide Description Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), and QT interval corrected for heart rate using Fridericia's formula (QTcF). Increase and decrease are signified by ↑ and ↓, respectively.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 29 62
Measure Type: Number
Unit of Measure: participants
HR <=50 and >30 bpm ↓ from BL; n=33, 28, 61 0 0 0
HR >=120 and >30 bpm ↑ from BL; n=33, 28, 61 0 0 0
PR Interval <120 msec; n=33, 27, 60 1 0 1
PR Interval >220 msec; n=33, 27, 60 1 0 1
QTcB Interval >480 msec; n=33, 27, 60 0 0 0
QTcB Interval >60 msec ↑ from BL; n=33, 27, 60 0 0 0
QTcF Interval >480 msec; n=33, 27, 60 0 0 0
QTcF Interval >60 msec ↑ from BL; n=33, 27, 60 0 0 0
7.Primary Outcome
Title Number of Participants With Sleep Attacks at Baseline and Endpoint
Hide Description To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 29 62
Measure Type: Number
Unit of Measure: participants
Participants with >=1 Sleep Attacks at Baseline 0 0 0
Participants with >=1 Sleep Attacks at Endpoint 0 0 0
8.Primary Outcome
Title Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL)
Hide Description The MIDI is a validated assessment of impulsive behavior consisting of a semistructured clinical interview assessing pathological gambling, trichotillomania (compulsive hair-pulling), kleptomania (compulsive stealing), pyromania (compulsive fire-setting), intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.
Time Frame Baseline, Post-baseline (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 29 62
Measure Type: Number
Unit of Measure: participants
BL Pathological Gambling; n=33, 29, 62 0 0 0
BL Trichotillomania; n=33, 29, 62 0 0 0
BL Kleptomania; n=33, 29, 62 0 0 0
BL Pyromania; n=33, 29, 62 0 0 0
BL Intermittent Explosive Disorder; n=33, 29, 62 0 0 0
BL Compulsive Buying; n=33, 29, 62 0 1 1
BL Compulsive Sexual Behavior; n=33, 29, 62 0 1 1
PBL Pathological Gambling; n=33, 27, 60 0 0 0
PBL Trichotillomania; n=33, 27, 60 0 0 0
PBL Kleptomania; n=33, 27, 60 0 0 0
PBL Pyromania; n=33, 27, 60 0 0 0
PBL Intermittent Explosive Disorder; n=33, 27, 60 0 0 0
PBL Compulsive Buying; n=33, 27, 60 1 0 1
PBL Compulsive Sexual Behavior; n=33, 27, 60 2 0 2
9.Primary Outcome
Title Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint
Hide Description The AIMS is an investigator-completed rating scale that has a total of 12 items rating involuntary movements of various areas of the participant's body. Items 1 through 10 are rated on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe), and items 11 and 12 are yes/no questions concerning problems with teeth or dentures. The total AIMS score was calculated by summing items 1-10, with a possible range of 0-40; a negative change indicates improvement. The AIMS was to be performed at consistent times, when the subject was experiencing his/her worst "On" time (dyskinesia [involuntary muscle movement]).
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 29 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline; n=33, 29, 62 6.1  (6.0) 5.3  (6.3) 5.7  (6.1)
Change from Baseline at Endpoint; n=33, 27, 60 6.1  (6.0) 5.0  (6.3) 5.6  (6.1)
10.Primary Outcome
Title Number of Participants With Confirmed Cases of Melanoma
Hide Description A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination/end of study by a dermatologist experienced with the diagnosis of the condition. If a suspicious lesion was present, a biopsy was obtained for proper diagnosis.
Time Frame up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 29 62
Measure Type: Number
Unit of Measure: participants
0 0 0
11.Primary Outcome
Title Number of Participants With Clinically Significant Neurological Examination Findings
Hide Description The neurologic examination was to be done during "On" time. The neurological examination assessed: cranial nerves – assessment of cranial nerves II – XII, excluding fundoscopic examination; motor system – assessment of tone, strength, and abnormal movements; sensory system – including light touch, pinprick, joint position, and vibratory sense; reflexes – assessment of deep tendon reflexes and plantar responses (Babinski sign); coordination – assessment of upper and lower extremities; gait – assessment of base and tandem gait; station – assessment of posture and stability.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had a neurological examination.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 19 15 34
Measure Type: Number
Unit of Measure: participants
Cranial Nerve 0 0 0
Motor System 3 2 5
Sensory System 2 1 3
Reflexes 1 1 2
Coordination 1 0 1
Gait 2 2 4
Station 2 2 4
12.Primary Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS) Findings
Hide Description The Columbia-Suicide Severity Rating Scale (C-SSRS) is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187-3-3003 LCIG infusion with a C-SSRS assessment during the study.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 12 7 19
Measure Type: Number
Unit of Measure: participants
Participants with Suicidal Ideations 0 0 0
Participants with Suicidal Ideations Only 0 0 0
Participants with Suicidal Behaviors 0 0 0
Participants with Suicidal Behaviors or Ideations 0 0 0
13.Primary Outcome
Title Number of Participants Taking at Least 1 Concomitant Medication During the Study
Hide Description Concomitant medications include medications started on or after the first open-label LCIG infusion as well as medications started prior to the first open-label infusion but continued during the study.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 29 62
Measure Type: Number
Unit of Measure: participants
33 29 62
14.Secondary Outcome
Title Change From Baseline in Average Daily "Off" Time at Endpoint
Hide Description Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 32 27 59
Mean (Standard Deviation)
Unit of Measure: hours
Baseline 2.87  (2.18) 5.18  (2.05) 3.92  (2.40)
Change from Baseline at Endpoint -0.42  (2.67) -2.34  (2.78) -1.30  (2.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint
Hide Description Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 32 27 59
Mean (Standard Deviation)
Unit of Measure: hours
Baseline 1.09  (2.07) 0.82  (1.54) 0.97  (1.84)
Change from Baseline at Endpoint -0.58  (2.18) 0.15  (2.17) -0.24  (2.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.394
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Month 12
Hide Description Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. “On" time without troublesome dyskinesia (involuntary muscle movement) is defined as "on" time without dyskinesia and "on" time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for "on" time without troublesome dyskinesia indicates improvement.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 32 27 59
Mean (Standard Deviation)
Unit of Measure: hours
Baseline 12.04  (2.42) 10.00  (2.62) 11.11  (2.69)
Change from Baseline at Endpoint 1.00  (2.58) 2.19  (3.70) 1.54  (3.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint
Hide Description The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment; n=number of participants with assessment at timepoint.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 29 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
CGI-S at Baseline; n=32, 28, 60 3.0  (1.3) 3.7  (1.3) 3.3  (1.3)
CGI-I at Endpoint; n=33, 29, 62 2.1  (1.2) 2.3  (1.6) 2.2  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint
Hide Description The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 1.6  (1.8) 1.2  (1.0) 1.4  (1.5)
Change from Baseline at Endpoint 0.3  (1.9) 0.7  (1.7) 0.5  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint
Hide Description The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 8.6  (6.5) 12.1  (7.0) 10.1  (6.9)
Change from Baseline at Endpoint 0.5  (3.4) -1.0  (7.0) -0.2  (5.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.766
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint
Hide Description The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 25 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 16.2  (12.7) 19.0  (10.5) 17.4  (11.8)
Change from Baseline at Endpoint 1.5  (7.0) -0.5  (10.4) 0.6  (8.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint
Hide Description The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 representing no disability.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 25 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 26.4  (18.9) 32.4  (16.1) 29.0  (17.8)
Change from Baseline at Endpoint 2.3  (9.0) -1.0  (15.0) 0.9  (12.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.583
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint
Hide Description The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.8  (2.7) 7.0  (3.2) 6.3  (3.0)
Change from Baseline at Endpoint -1.6  (2.5) -1.4  (3.0) -1.5  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint
Hide Description The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 32 26 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 22.2  (17.3) 32.8  (17.0) 26.9  (17.8)
Change from Baseline at Endpoint 1.5  (12.7) -3.5  (13.4) -0.7  (13.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.670
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint
Hide Description The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 27.6  (24.1) 43.8  (25.4) 34.7  (25.8)
Change from Baseline at Endpoint 2.3  (19.5) -8.5  (18.6) -2.5  (19.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.341
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint
Hide Description The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 25.9  (24.8) 39.4  (21.3) 31.9  (24.1)
Change from Baseline at Endpoint 0.4  (14.0) -6.7  (19.9) -2.8  (17.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.220
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint
Hide Description The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 32 26 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 20.1  (20.3) 26.3  (17.2) 22.8  (19.1)
Change from Baseline at Endpoint 4.0  (16.4) 1.9  (18.1) 3.1  (17.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.174
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint
Hide Description The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 32 26 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 16.4  (21.3) 23.8  (19.0) 19.7  (20.5)
Change from Baseline at Endpoint 0.2  (15.2) -6.3  (20.7) -2.7  (18.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.259
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint
Hide Description The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 11.9  (18.2) 17.1  (17.8) 14.2  (18.0)
Change from Baseline at Endpoint 1.8  (17.2) -2.7  (15.5) -0.2  (16.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.922
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint
Hide Description The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 15.0  (14.1) 24.8  (18.9) 19.3  (16.9)
Change from Baseline at Endpoint 1.3  (16.3) 3.8  (16.7) 2.4  (16.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.258
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint
Hide Description The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 15.9  (16.3) 31.7  (23.2) 22.9  (21.0)
Change from Baseline at Endpoint 8.3  (18.4) -1.9  (15.3) 3.8  (17.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.104
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
31.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint
Hide Description The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Endpoint 32.1  (25.8) 34.9  (22.9) 33.3  (24.4)
Change from Baseline at Endpoint -2.8  (18.8) 1.0  (19.5) -1.1  (19.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.650
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
32.Secondary Outcome
Title Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint
Hide Description The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.778  (0.144) 0.676  (0.158) 0.733  (0.158)
Change from Baseline at Endpoint -0.009  (0.173) -0.006  (0.220) -0.008  (0.193)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.759
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
33.Secondary Outcome
Title Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint
Hide Description The EQ-5D VAS records the participant's self-rated health on a scale from 0–100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'
Time Frame Baseline, Endpoint (Month 12 or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 76.7  (16.2) 62.1  (22.0) 70.2  (20.2)
Change from Baseline at Endpoint -0.9  (15.1) 4.5  (15.5) 1.5  (15.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.459
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
34.Secondary Outcome
Title Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint
Hide Description The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, and 4=nearly always). The caregiver burden is evaluated by the total score (range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.
Time Frame Baseline, Endpoint (Month 12 months or last post-baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description:

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Overall Number of Participants Analyzed 24 20 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 22.1  (15.3) 27.0  (17.2) 24.3  (16.2)
Change from Baseline at Endpoint 1.1  (9.7) -1.8  (9.0) -0.2  (9.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG (All Participants)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.899
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days.
Adverse Event Reporting Description Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
 
Arm/Group Title LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Hide Arm/Group Description

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.

All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
All-Cause Mortality
LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/33 (15.15%)   9/29 (31.03%)   14/62 (22.58%) 
Cardiac disorders       
ANGINA PECTORIS  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
Gastrointestinal disorders       
ABDOMINAL PAIN  1  1/33 (3.03%)  1/29 (3.45%)  2/62 (3.23%) 
FAECALOMA  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
GASTROINTESTINAL HAEMORRHAGE  1  1/33 (3.03%)  0/29 (0.00%)  1/62 (1.61%) 
INTESTINAL ISCHAEMIA  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
INTESTINAL OBSTRUCTION  1  1/33 (3.03%)  0/29 (0.00%)  1/62 (1.61%) 
INTESTINAL PERFORATION  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
PERITONITIS  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
General disorders       
ASTHENIA  1  1/33 (3.03%)  1/29 (3.45%)  2/62 (3.23%) 
COMPLICATION OF DEVICE INSERTION  1  1/33 (3.03%)  2/29 (6.90%)  3/62 (4.84%) 
Hepatobiliary disorders       
CHOLECYSTITIS  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
Infections and infestations       
GASTROENTERITIS  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
PNEUMONIA  1  0/33 (0.00%)  2/29 (6.90%)  2/62 (3.23%) 
SEPSIS  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
Injury, poisoning and procedural complications       
GASTROINTESTINAL INJURY  1  1/33 (3.03%)  0/29 (0.00%)  1/62 (1.61%) 
PROCEDURAL PAIN  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
Investigations       
COLONOSCOPY  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
Musculoskeletal and connective tissue disorders       
LUMBAR SPINAL STENOSIS  1  1/33 (3.03%)  0/29 (0.00%)  1/62 (1.61%) 
MUSCLE RIGIDITY  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
Nervous system disorders       
SYNCOPE  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
Psychiatric disorders       
DELUSION  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
HALLUCINATION  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
HALLUCINATION, AUDITORY  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
PARANOIA  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
Renal and urinary disorders       
RENAL MASS  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
URETHRAL STENOSIS  1  1/33 (3.03%)  0/29 (0.00%)  1/62 (1.61%) 
URINARY RETENTION  1  1/33 (3.03%)  0/29 (0.00%)  1/62 (1.61%) 
Reproductive system and breast disorders       
BENIGN PROSTATIC HYPERPLASIA  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders       
HYPOXIA  1  1/33 (3.03%)  0/29 (0.00%)  1/62 (1.61%) 
PNEUMONIA ASPIRATION  1  1/33 (3.03%)  0/29 (0.00%)  1/62 (1.61%) 
Vascular disorders       
HYPERTENSION  1  0/33 (0.00%)  1/29 (3.45%)  1/62 (1.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LCIG (Previous: LCIG + Placebo Capsules) LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) LCIG (All Participants)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/33 (87.88%)   26/29 (89.66%)   55/62 (88.71%) 
Gastrointestinal disorders       
ABDOMINAL PAIN  1  3/33 (9.09%)  0/29 (0.00%)  3/62 (4.84%) 
CONSTIPATION  1  4/33 (12.12%)  5/29 (17.24%)  9/62 (14.52%) 
DIARRHOEA  1  2/33 (6.06%)  2/29 (6.90%)  4/62 (6.45%) 
NAUSEA  1  4/33 (12.12%)  5/29 (17.24%)  9/62 (14.52%) 
SALIVARY HYPERSECRETION  1  0/33 (0.00%)  2/29 (6.90%)  2/62 (3.23%) 
VOMITING  1  2/33 (6.06%)  3/29 (10.34%)  5/62 (8.06%) 
General disorders       
COMPLICATION OF DEVICE INSERTION  1  2/33 (6.06%)  0/29 (0.00%)  2/62 (3.23%) 
FATIGUE  1  0/33 (0.00%)  2/29 (6.90%)  2/62 (3.23%) 
OEDEMA PERIPHERAL  1  2/33 (6.06%)  1/29 (3.45%)  3/62 (4.84%) 
Infections and infestations       
POSTOPERATIVE WOUND INFECTION  1  5/33 (15.15%)  6/29 (20.69%)  11/62 (17.74%) 
RHINITIS  1  0/33 (0.00%)  2/29 (6.90%)  2/62 (3.23%) 
UPPER RESPIRATORY TRACT INFECTION  1  3/33 (9.09%)  0/29 (0.00%)  3/62 (4.84%) 
URINARY TRACT INFECTION  1  5/33 (15.15%)  4/29 (13.79%)  9/62 (14.52%) 
Injury, poisoning and procedural complications       
CONTUSION  1  4/33 (12.12%)  1/29 (3.45%)  5/62 (8.06%) 
EXCORIATION  1  0/33 (0.00%)  2/29 (6.90%)  2/62 (3.23%) 
FALL  1  7/33 (21.21%)  6/29 (20.69%)  13/62 (20.97%) 
GASTROINTESTINAL STOMA COMPLICATION  1  0/33 (0.00%)  2/29 (6.90%)  2/62 (3.23%) 
INCISION SITE ERYTHEMA  1  7/33 (21.21%)  11/29 (37.93%)  18/62 (29.03%) 
LACERATION  1  1/33 (3.03%)  2/29 (6.90%)  3/62 (4.84%) 
POST PROCEDURAL DISCHARGE  1  3/33 (9.09%)  5/29 (17.24%)  8/62 (12.90%) 
POST PROCEDURAL HAEMORRHAGE  1  1/33 (3.03%)  2/29 (6.90%)  3/62 (4.84%) 
PROCEDURAL PAIN  1  4/33 (12.12%)  3/29 (10.34%)  7/62 (11.29%) 
PROCEDURAL SITE REACTION  1  2/33 (6.06%)  3/29 (10.34%)  5/62 (8.06%) 
TOOTH FRACTURE  1  1/33 (3.03%)  2/29 (6.90%)  3/62 (4.84%) 
Investigations       
BLOOD HOMOCYSTEINE INCREASED  1  5/33 (15.15%)  2/29 (6.90%)  7/62 (11.29%) 
VITAMIN B6 DECREASED  1  8/33 (24.24%)  5/29 (17.24%)  13/62 (20.97%) 
WEIGHT DECREASED  1  2/33 (6.06%)  3/29 (10.34%)  5/62 (8.06%) 
X-RAY ABNORMAL  1  2/33 (6.06%)  0/29 (0.00%)  2/62 (3.23%) 
Metabolism and nutrition disorders       
DECREASED APPETITE  1  1/33 (3.03%)  2/29 (6.90%)  3/62 (4.84%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  5/33 (15.15%)  2/29 (6.90%)  7/62 (11.29%) 
BACK PAIN  1  2/33 (6.06%)  4/29 (13.79%)  6/62 (9.68%) 
MUSCLE SPASMS  1  1/33 (3.03%)  2/29 (6.90%)  3/62 (4.84%) 
NECK PAIN  1  0/33 (0.00%)  2/29 (6.90%)  2/62 (3.23%) 
PAIN IN EXTREMITY  1  2/33 (6.06%)  3/29 (10.34%)  5/62 (8.06%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
MELANOCYTIC NAEVUS  1  2/33 (6.06%)  1/29 (3.45%)  3/62 (4.84%) 
SEBORRHOEIC KERATOSIS  1  5/33 (15.15%)  3/29 (10.34%)  8/62 (12.90%) 
Nervous system disorders       
CARPAL TUNNEL SYNDROME  1  2/33 (6.06%)  0/29 (0.00%)  2/62 (3.23%) 
DISTURBANCE IN ATTENTION  1  2/33 (6.06%)  0/29 (0.00%)  2/62 (3.23%) 
DYSKINESIA  1  4/33 (12.12%)  3/29 (10.34%)  7/62 (11.29%) 
DYSTONIA  1  1/33 (3.03%)  4/29 (13.79%)  5/62 (8.06%) 
FREEZING PHENOMENON  1  4/33 (12.12%)  3/29 (10.34%)  7/62 (11.29%) 
HEADACHE  1  5/33 (15.15%)  1/29 (3.45%)  6/62 (9.68%) 
PARKINSON'S DISEASE  1  4/33 (12.12%)  4/29 (13.79%)  8/62 (12.90%) 
POLYNEUROPATHY  1  3/33 (9.09%)  3/29 (10.34%)  6/62 (9.68%) 
RESTLESS LEGS SYNDROME  1  2/33 (6.06%)  2/29 (6.90%)  4/62 (6.45%) 
Psychiatric disorders       
ABNORMAL DREAMS  1  0/33 (0.00%)  2/29 (6.90%)  2/62 (3.23%) 
ANXIETY  1  3/33 (9.09%)  2/29 (6.90%)  5/62 (8.06%) 
DEPRESSION  1  3/33 (9.09%)  2/29 (6.90%)  5/62 (8.06%) 
HALLUCINATION  1  1/33 (3.03%)  2/29 (6.90%)  3/62 (4.84%) 
INSOMNIA  1  2/33 (6.06%)  7/29 (24.14%)  9/62 (14.52%) 
SLEEP ATTACKS  1  0/33 (0.00%)  3/29 (10.34%)  3/62 (4.84%) 
Renal and urinary disorders       
POLLAKIURIA  1  3/33 (9.09%)  0/29 (0.00%)  3/62 (4.84%) 
Skin and subcutaneous tissue disorders       
EXCESSIVE GRANULATION TISSUE  1  2/33 (6.06%)  4/29 (13.79%)  6/62 (9.68%) 
LENTIGO  1  2/33 (6.06%)  1/29 (3.45%)  3/62 (4.84%) 
RASH  1  0/33 (0.00%)  2/29 (6.90%)  2/62 (3.23%) 
Vascular disorders       
ORTHOSTATIC HYPOTENSION  1  3/33 (9.09%)  3/29 (10.34%)  6/62 (9.68%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00360568     History of Changes
Other Study ID Numbers: S187.3.003
2006-000578-53 ( EudraCT Number )
First Submitted: August 3, 2006
First Posted: August 4, 2006
Results First Submitted: January 12, 2015
Results First Posted: January 16, 2015
Last Update Posted: January 16, 2015