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Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00335153
Recruitment Status : Completed
First Posted : June 9, 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
Condition Advanced Parkinson's Disease
Interventions Drug: Levodopa-carbidopa intestinal gel
Device: CADD-Legacy® 1400 ambulatory infusion pump
Device: PEG tube
Device: J-tube
Enrollment 354
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description

All participants were to receive levodopa-carbidopa intestinal gel (LCIG), via the nasojejunal (NJ) tube during the NJ Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Period Title: Nasojejunal (NJ) Test Period
Started 354
Completed 324
Not Completed 30
Reason Not Completed
Adverse Event             5
Lack of Efficacy             5
Withdrawal by Subject             12
Administrative             1
Protocol Violation             7
Period Title: Post-PEG-J Long-Term Treatment Period
Started 324
Completed 272
Not Completed 52
Reason Not Completed
Adverse Event             22
Lack of Efficacy             2
Withdrawal by Subject             13
Administrative             13
Protocol Violation             2
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Baseline Participants 354
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 354 participants
64.1  (9.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants
<65 years 171
>=65 years 183
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 354 participants
Female
152
  42.9%
Male
202
  57.1%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (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 Screening through Day 378 + 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 354
Measure Type: Number
Unit of Measure: participants
Deaths 8
TE Deaths 7
>=1 SAE 111
>=1TESAE 108
>=1 TEAE Leading to Study Termination 27
>=1 TEAE 323
>=1 Severe TEAE 102
>=1 Possibly or Probably Treatment Related TEAE 272
No TEAE 31
2.Primary Outcome
Title Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period
Hide Description Complications of the infusion device were collected during the NJ Test period. Pump, intestinal tube, NJ tube, 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 post-procedural hemorrhage.
Time Frame NJ Test Period (from 2 to 14 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 354
Measure Type: Number
Unit of Measure: participants
>=1 Complication 90
Pump Complication 7
Intestinal Tube Complication 4
NJ Tube Complication 68
Other Complications 25
3.Primary Outcome
Title Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy – With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods
Hide Description Complications of the infusion device were collected during the PEG-J Surgery and Post-PEG Long-Term Treatment periods. Pump, PEG-J, 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 post-procedural hemorrhage.
Time Frame PEG-J Surgery Period (from 2 to 14 days) through the Long Term Treatment Period (Day 28 to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 324
Measure Type: Number
Unit of Measure: participants
>=1 Complication 282
Pump Complication 116
Intestinal Tube Complication 165
PEG-J Complication 114
Stoma Complication 116
Other Complication 114
4.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Values for Hematology Parameters
Hide Description Potentially clinically significant values for red blood cells (RBCs), hemoglobin, and hematocrit are specified for females (f) and males (m) separately in the category rows.
Time Frame Screening through Day 378
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 324
Measure Type: Number
Unit of Measure: participants
RBCs <2.0*10^12/L (f), <2.5*10^12/L (m); n=316 0
Hemoglobin <90 g/L (f), <100 g/L (m); n=316 4
Hematocrit <30% (f), <34% (m); n=315 27
White Blood Cells <2.8*10^9/L; n=316 3
White Blood Cells >16.0*10^9/L; n=316 0
Neutrophils <1.2*10^9/L; n=316 0
Lymphocytes <0.75*10^9/L; n=316 21
Lymphocytes >80%; n=316 0
Platelet Count <95*10^9/L; n=315 1
Platelet Count >700*10^9/L; n=315 0
Mean Corpuscular Volume <60 fL; n=315 0
Mean Corpuscular Volume >120 fL; n=315 0
Eosinophils >10%; n=316 7
Monocytes >30%; n=316 0
5.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters
Hide Description Terms abbreviated in the table include aspartate aminotransferase (AST), upper limit of normal (ULN), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), blood urea nitrogen (BUN), female (f), and male (m).
Time Frame Screening through Day 378
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 324
Measure Type: Number
Unit of Measure: participants
AST >3*ULN; n=315 1
ALT >3*ULN; n=315 0
GGT >3*ULN; n=315 3
LDH >3*ULN; n=315 0
Alkaline Phosphatase >400 U/L; n=315 0
Total Protein <45 g/L; n=315 0
Total Bilirubin >2*ULN; n=315 0
Creatine Kinase >3*ULN; n=315 7
Sodium <126 mmol/L; n=315 2
Sodium >156 mmol/L; n=315 2
Potassium <3.0 mmol/L; n=315 1
Potassium >6.0 mmol/L; n=315 1
Calcium <1.75 mmol/L; n=315 2
Calcium >3.0 mmol/L; n=315 0
BUN >10.8 mmol/L; n=77 4
Creatinine >177 mcmol/L; n=315 3
Uric Acid >500 mcmol/L (f), >590 mcmol/L (m);n=315 0
Glucose (nonfasting) <2.78 mmol/L; n=315 1
Glucose (nonfasting) >16.0 mmol/L; n=315 1
Cholesterol >12.9 mmol/L; n=315 0
Triglycerides >5.6 mmol/L; n=315 2
6.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 up to 56 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 324
Measure Type: Number
Unit of Measure: participants
SuSBP >=180 and >40 mm Hg ↑ from BL; n=324 4
SuSBP <=90 and >30 mm Hg ↓ from BL; n=324 17
StSBP >=180 and >40 mm Hg ↑ from BL; n=324 2
StSBP <=90 and >30 mm Hg ↓ from BL; n=324 35
OSBP: ↓ >=30 mm Hg (Supine to Standing); n=324 80
SuDBP >=105 and >30 mm Hg ↑ from BL; n=324 5
SuDBP <=50 and >30 mm Hg ↓ from BL; n=324 11
StDBP >=105 and >30 mm Hg ↑ from BL; n=324 8
StDBP <=50 and >30 mm Hg ↓ from BL; n=324 12
ODBP: ↓ >=20 mm Hg (Supine to Standing); n=324 59
SuP >=120 and >30 bpm ↑ from BL; n=324 0
SuP <=50 and >30 bpm ↓ from BL; n=324 1
StP >=120 and >30 bpm ↑ from BL; n=324 0
StP <=50 and >30 bpm ↓ from BL; n=324 0
Temp >=38.3 and >1.1°C ↑ from BL; n=322 2
Weight >=7% ↑ from BL; n=272 25
Weight <=7% ↓ from BL; n=272 79
7.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 Screening through Day 378
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with given assessment.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 324
Measure Type: Number
Unit of Measure: participants
HR <=50 and >30 bpm ↓ from BL; n=321 1
HR >=120 and >30 bpm ↑ from BL; n=321 1
PR Interval <120 msec; n=321 6
PR Interval >220 msec; n=321 26
QTcB Interval >480 msec; n=319 15
QTcB Interval >60 msec ↑ from BL; n=309 4
QTcF Interval >480 msec; n=319 7
QTcF Interval >60 msec ↑ from BL; n=309 3
8.Primary Outcome
Title Number of Participants With Sleep Attacks at Baseline
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. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 324
Measure Type: Number
Unit of Measure: participants
Participants with >=1 Sleep Attacks 7
Number of Sleep Attacks Per Participant=1 4
Number of Sleep Attacks Per Participant=2 0
Number of Sleep Attacks Per Participant=3 0
Number of Sleep Attacks Per Participant>3 2
Number of Sleep Attacks Per Participant=Missing 1
Sleepiness/Drowsiness Prior to Sleep Attack 4
Bad Outcome/Problem Due to Sleep Attack 1
Number of Bad Outcomes/Problems=1 1
Number of Bad Outcomes/Problems=2 0
Number of Bad Outcomes/Problems=3 0
Number of Bad Outcomes/Problems>3 0
9.Primary Outcome
Title Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period
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. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.
Time Frame During the Post-PEG Long-Term Treatment Period (Day 28 through Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded) who had an assessment.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 321
Measure Type: Number
Unit of Measure: participants
Participants with >=1 Sleep Attacks 27
Number of Sleep Attacks Per Participant=1 11
Number of Sleep Attacks Per Participant=2 2
Number of Sleep Attacks Per Participant=3 5
Number of Sleep Attacks Per Participant>3 9
Sleepiness/Drowsiness Prior to Sleep Attack 11
Bad Outcome/Problem Due to Sleep Attack 2
Number of Bad Outcomes/Problems=1 2
Number of Bad Outcomes/Problems=2 0
Number of Bad Outcomes/Problems=3 0
Number of Bad Outcomes/Problems>3 0
10.Primary Outcome
Title Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period
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, during the Post-PEG Long-term Treatment Period (Day 28 through Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with an assessment at timepoint.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 324
Measure Type: Number
Unit of Measure: participants
BL Compulsive Buying; n=322 0
BL Kleptomania; n=322 0
BL Trichotillomania; n=322 0
BL Intermittent Explosive Disorder; n=322 0
BL Pyromania; n=322 0
BL Pathological Gambling; n=322 2
BL Compulsive Sexual Behavior; n=322 9
PPLT Compulsive Buying; n=318 3
PPLT Kleptomania; n=318 0
PPLT Trichotillomania; n=318 0
PPLT Intermittent Explosive Disorder; n=318 0
PPLT Pyromania; n=318 0
PPLT Pathological Gambling; n=318 6
PPLT Compulsive Sexual Behavior; n=318 11
11.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 regarding issues 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 (last Post-PEG Long-Term Period visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment at timepoint.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 324
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline; n=318 9.6  (8.1)
Change from Baseline at Endpoint; n=317 -1.7  (9.0)
12.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 or 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 Screening up to Day 378
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 354
Measure Type: Number
Unit of Measure: participants
0
13.Primary Outcome
Title Number of Participants Taking at Least 1 Concomitant Medication During the Study
Hide Description Concomitant medications include those 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 Screening up to Day 378
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 354
Measure Type: Number
Unit of Measure: participants
349
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 307
Mean (Standard Deviation)
Unit of Measure: hours
Baseline 6.77  (2.37)
Change from Baseline at Endpoint -4.44  (2.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 307
Mean (Standard Deviation)
Unit of Measure: hours
Baseline 1.60  (2.03)
Change from Baseline at Endpoint -0.36  (2.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
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 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. "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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 307
Mean (Standard Deviation)
Unit of Measure: hours
Baseline 4.83  (2.72)
Change from Baseline at Endpoint 3.86  (4.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 316
Mean (Standard Deviation)
Unit of Measure: units on a scale
CGI-S Baseline 4.85  (0.84)
CGI-I at Endpoint 2.10  (0.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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 Month 12
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 288
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.2  (1.9)
Change from Baseline at Endpoint 0.0  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.974
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 288
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 17.5  (6.7)
Change from Baseline at Endpoint -4.4  (6.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 286
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 28.9  (13.7)
Change from Baseline at Endpoint -7.4  (13.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 287
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 48.6  (18.9)
Change from Baseline at Endpoint -11.7  (18.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 287
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 9.2  (2.9)
Change from Baseline at Endpoint -3.5  (3.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 317
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 42.7  (15.0)
Change from Baseline at Endpoint -6.9  (14.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 317
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 58.8  (22.8)
Change from Baseline at Endpoint -11.2  (23.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 317
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 50.7  (22.3)
Change from Baseline at Endpoint -8.3  (22.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 317
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 39.4  (21.8)
Change from Baseline at Endpoint -4.2  (19.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 317
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 32.5  (26.0)
CHange from Baseline at Endpoint -9.1  (22.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 315
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 17.2  (19.7)
Change from Baseline at Endpoint -0.3  (18.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.757
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 317
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 27.2  (18.6)
Change from Baseline to Endpoint -4.5  (18.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 317
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 34.3  (20.4)
Change from Baseline at Endpoint -3.9  (19.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 317
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 46.2  (22.9)
Change from Baseline at Endpoint -5.8  (22.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 313
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.588  (0.195)
Change from Baseline at Endpoint 0.064  (0.203)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 313
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 50.2  (21.0)
Change from Baseline at Endpoint 14.0  (24.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
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]
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 (last post-baseline visit up to Day 378)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description:

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Overall Number of Participants Analyzed 172
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 27.1  (13.2)
Change from Baseline at Endpoint 0.2  (10.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel (LCIG)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.824
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 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 NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
 
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description

All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

All-Cause Mortality
Levodopa-Carbidopa Intestinal Gel (LCIG)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Levodopa-Carbidopa Intestinal Gel (LCIG)
Affected / at Risk (%)
Total   108/354 (30.51%) 
Blood and lymphatic system disorders   
ANAEMIA  1  2/354 (0.56%) 
ANAEMIA VITAMIN B12 DEFICIENCY  1  1/354 (0.28%) 
LEUKOCYTOSIS  1  1/354 (0.28%) 
Cardiac disorders   
ATRIOVENTRICULAR BLOCK SECOND DEGREE  1  1/354 (0.28%) 
MYOCARDIAL INFARCTION  1  1/354 (0.28%) 
Endocrine disorders   
SECONDARY ADRENOCORTICAL INSUFFICIENCY  1  1/354 (0.28%) 
Eye disorders   
ANGLE CLOSURE GLAUCOMA  1  1/354 (0.28%) 
CATARACT  1  1/354 (0.28%) 
OPTIC ISCHAEMIC NEUROPATHY  1  1/354 (0.28%) 
Gastrointestinal disorders   
ABDOMINAL PAIN  1  10/354 (2.82%) 
ABDOMINAL PAIN UPPER  1  1/354 (0.28%) 
ACUTE ABDOMEN  1  2/354 (0.56%) 
BEZOAR  1  1/354 (0.28%) 
COLONIC POLYP  1  1/354 (0.28%) 
CONSTIPATION  1  2/354 (0.56%) 
DUODENAL PERFORATION  1  1/354 (0.28%) 
DYSPHAGIA  1  1/354 (0.28%) 
FAECALOMA  1  1/354 (0.28%) 
FLATULENCE  1  1/354 (0.28%) 
GASTRIC HYPOMOTILITY  1  1/354 (0.28%) 
GASTRITIS  1  1/354 (0.28%) 
HAEMORRHOIDAL HAEMORRHAGE  1  1/354 (0.28%) 
ILEUS PARALYTIC  1  1/354 (0.28%) 
INGUINAL HERNIA  1  1/354 (0.28%) 
INGUINAL HERNIA, OBSTRUCTIVE  1  1/354 (0.28%) 
INTESTINAL HAEMATOMA  1  1/354 (0.28%) 
INTESTINAL INFARCTION  1  1/354 (0.28%) 
INTESTINAL PERFORATION  1  1/354 (0.28%) 
INTESTINAL STENOSIS  1  1/354 (0.28%) 
LARGE INTESTINE PERFORATION  1  1/354 (0.28%) 
NAUSEA  1  2/354 (0.56%) 
PANCREATITIS  1  1/354 (0.28%) 
PERITONITIS  1  9/354 (2.54%) 
PNEUMATOSIS INTESTINALIS  1  1/354 (0.28%) 
PNEUMOPERITONEUM  1  8/354 (2.26%) 
SMALL INTESTINAL HAEMORRHAGE  1  1/354 (0.28%) 
SMALL INTESTINAL OBSTRUCTION  1  2/354 (0.56%) 
VOMITING  1  1/354 (0.28%) 
General disorders   
ASTHENIA  1  1/354 (0.28%) 
COMPLICATION OF DEVICE INSERTION  1  21/354 (5.93%) 
DEATH  1  2/354 (0.56%) 
DEVICE DISLOCATION  1  5/354 (1.41%) 
DEVICE OCCLUSION  1  3/354 (0.85%) 
IMPLANT SITE ULCER  1  1/354 (0.28%) 
MEDICAL DEVICE COMPLICATION  1  1/354 (0.28%) 
PAIN  1  1/354 (0.28%) 
UNINTENTIONAL MEDICAL DEVICE REMOVAL BY PATIENT  1  2/354 (0.56%) 
Hepatobiliary disorders   
CHOLECYSTITIS  1  1/354 (0.28%) 
HEPATIC FAILURE  1  1/354 (0.28%) 
HEPATIC STEATOSIS  1  1/354 (0.28%) 
Infections and infestations   
ABDOMINAL INFECTION  1  1/354 (0.28%) 
CLOSTRIDIUM DIFFICILE COLITIS  1  1/354 (0.28%) 
GASTROENTERITIS  1  1/354 (0.28%) 
GASTROENTERITIS VIRAL  1  1/354 (0.28%) 
LUNG ABSCESS  1  1/354 (0.28%) 
PERITONEAL ABSCESS  1  1/354 (0.28%) 
PNEUMONIA  1  7/354 (1.98%) 
POSTOPERATIVE WOUND INFECTION  1  3/354 (0.85%) 
PYELONEPHRITIS  1  2/354 (0.56%) 
PYELONEPHRITIS ACUTE  1  1/354 (0.28%) 
SEPSIS  1  1/354 (0.28%) 
SEPTIC SHOCK  1  1/354 (0.28%) 
URINARY TRACT INFECTION  1  1/354 (0.28%) 
UROSEPSIS  1  1/354 (0.28%) 
VIRAL DIARRHOEA  1  1/354 (0.28%) 
Injury, poisoning and procedural complications   
BRAIN CONTUSION  1  1/354 (0.28%) 
CONTUSION  1  2/354 (0.56%) 
FALL  1  1/354 (0.28%) 
GASTROINTESTINAL STOMA COMPLICATION  1  1/354 (0.28%) 
HIP FRACTURE  1  6/354 (1.69%) 
LACERATION  1  1/354 (0.28%) 
POST PROCEDURAL COMPLICATION  1  2/354 (0.56%) 
POST PROCEDURAL HAEMORRHAGE  1  1/354 (0.28%) 
POSTOPERATIVE ILEUS  1  1/354 (0.28%) 
RADIUS FRACTURE  1  2/354 (0.56%) 
RIB FRACTURE  1  1/354 (0.28%) 
STERNAL FRACTURE  1  1/354 (0.28%) 
THORACIC VERTEBRAL FRACTURE  1  1/354 (0.28%) 
ULNA FRACTURE  1  1/354 (0.28%) 
UPPER LIMB FRACTURE  1  1/354 (0.28%) 
Investigations   
AMINO ACID LEVEL INCREASED  1  1/354 (0.28%) 
BLOOD LACTIC ACID INCREASED  1  1/354 (0.28%) 
WEIGHT DECREASED  1  4/354 (1.13%) 
Metabolism and nutrition disorders   
CACHEXIA  1  1/354 (0.28%) 
DECREASED APPETITE  1  1/354 (0.28%) 
FOLATE DEFICIENCY  1  1/354 (0.28%) 
HYPERHOMOCYSTEINAEMIA  1  1/354 (0.28%) 
HYPONATRAEMIA  1  1/354 (0.28%) 
MALNUTRITION  1  2/354 (0.56%) 
METABOLIC ACIDOSIS  1  1/354 (0.28%) 
VITAMIN B12 DEFICIENCY  1  1/354 (0.28%) 
VITAMIN B6 DEFICIENCY  1  1/354 (0.28%) 
Musculoskeletal and connective tissue disorders   
BACK PAIN  1  3/354 (0.85%) 
BURSITIS  1  1/354 (0.28%) 
RHABDOMYOLYSIS  1  1/354 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BASAL CELL CARCINOMA  1  2/354 (0.56%) 
BENIGN SALIVARY GLAND NEOPLASM  1  1/354 (0.28%) 
COLON ADENOMA  1  1/354 (0.28%) 
PROSTATE CANCER  1  2/354 (0.56%) 
RENAL CELL CARCINOMA  1  1/354 (0.28%) 
SQUAMOUS CELL CARCINOMA  1  1/354 (0.28%) 
SQUAMOUS CELL CARCINOMA OF SKIN  1  1/354 (0.28%) 
Nervous system disorders   
CEREBROVASCULAR ACCIDENT  1  1/354 (0.28%) 
DYSKINESIA  1  1/354 (0.28%) 
GUILLAIN-BARRE SYNDROME  1  2/354 (0.56%) 
HEADACHE  1  1/354 (0.28%) 
HEPATIC ENCEPHALOPATHY  1  1/354 (0.28%) 
HYPERKINESIA  1  1/354 (0.28%) 
MONOPLEGIA  1  1/354 (0.28%) 
MYELOPATHY  1  1/354 (0.28%) 
NEUROPATHY PERIPHERAL  1  1/354 (0.28%) 
ON AND OFF PHENOMENON  1  2/354 (0.56%) 
PARKINSON'S DISEASE  1  8/354 (2.26%) 
PARTIAL SEIZURES  1  1/354 (0.28%) 
PERIPHERAL SENSORIMOTOR NEUROPATHY  1  2/354 (0.56%) 
PERIPHERAL SENSORY NEUROPATHY  1  1/354 (0.28%) 
POLYNEUROPATHY  1  9/354 (2.54%) 
SYNCOPE  1  2/354 (0.56%) 
Psychiatric disorders   
ACUTE PSYCHOSIS  1  1/354 (0.28%) 
AGITATION  1  1/354 (0.28%) 
ANXIETY  1  1/354 (0.28%) 
COMPLETED SUICIDE  1  2/354 (0.56%) 
DELUSION  1  1/354 (0.28%) 
DEPRESSION  1  4/354 (1.13%) 
HALLUCINATION  1  2/354 (0.56%) 
PSYCHOTIC DISORDER  1  2/354 (0.56%) 
STEREOTYPY  1  1/354 (0.28%) 
SUBSTANCE ABUSE  1  1/354 (0.28%) 
SUICIDE ATTEMPT  1  2/354 (0.56%) 
Renal and urinary disorders   
CALCULUS URETERIC  1  2/354 (0.56%) 
NEPHROLITHIASIS  1  1/354 (0.28%) 
RENAL FAILURE ACUTE  1  1/354 (0.28%) 
Respiratory, thoracic and mediastinal disorders   
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  1/354 (0.28%) 
PLEURISY  1  1/354 (0.28%) 
PNEUMONIA ASPIRATION  1  1/354 (0.28%) 
PNEUMOTHORAX  1  2/354 (0.56%) 
PULMONARY EMBOLISM  1  2/354 (0.56%) 
RESPIRATORY FAILURE  1  1/354 (0.28%) 
Skin and subcutaneous tissue disorders   
EXCESSIVE GRANULATION TISSUE  1  1/354 (0.28%) 
Surgical and medical procedures   
KNEE ARTHROPLASTY  1  2/354 (0.56%) 
Vascular disorders   
DEEP VEIN THROMBOSIS  1  1/354 (0.28%) 
HYPERTENSIVE CRISIS  1  1/354 (0.28%) 
ORTHOSTATIC HYPOTENSION  1  1/354 (0.28%) 
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%
Levodopa-Carbidopa Intestinal Gel (LCIG)
Affected / at Risk (%)
Total   278/354 (78.53%) 
Gastrointestinal disorders   
ABDOMINAL PAIN  1  92/354 (25.99%) 
CONSTIPATION  1  55/354 (15.54%) 
DIARRHOEA  1  27/354 (7.63%) 
DYSPEPSIA  1  24/354 (6.78%) 
NAUSEA  1  60/354 (16.95%) 
VOMITING  1  32/354 (9.04%) 
General disorders   
COMPLICATION OF DEVICE INSERTION  1  102/354 (28.81%) 
Infections and infestations   
POSTOPERATIVE WOUND INFECTION  1  47/354 (13.28%) 
URINARY TRACT INFECTION  1  37/354 (10.45%) 
Injury, poisoning and procedural complications   
FALL  1  50/354 (14.12%) 
INCISION SITE ERYTHEMA  1  43/354 (12.15%) 
INCISION SITE PAIN  1  21/354 (5.93%) 
POST PROCEDURAL DISCHARGE  1  26/354 (7.34%) 
PROCEDURAL PAIN  1  67/354 (18.93%) 
PROCEDURAL SITE REACTION  1  32/354 (9.04%) 
Investigations   
BLOOD HOMOCYSTEINE INCREASED  1  20/354 (5.65%) 
VITAMIN B6 DECREASED  1  20/354 (5.65%) 
WEIGHT DECREASED  1  32/354 (9.04%) 
Metabolism and nutrition disorders   
DECREASED APPETITE  1  18/354 (5.08%) 
Musculoskeletal and connective tissue disorders   
BACK PAIN  1  23/354 (6.50%) 
MUSCULOSKELETAL PAIN  1  19/354 (5.37%) 
PAIN IN EXTREMITY  1  19/354 (5.37%) 
Nervous system disorders   
DIZZINESS  1  18/354 (5.08%) 
DYSKINESIA  1  31/354 (8.76%) 
HEADACHE  1  30/354 (8.47%) 
PARKINSON'S DISEASE  1  25/354 (7.06%) 
Psychiatric disorders   
ANXIETY  1  40/354 (11.30%) 
DEPRESSION  1  25/354 (7.06%) 
INSOMNIA  1  67/354 (18.93%) 
SLEEP ATTACKS  1  25/354 (7.06%) 
Respiratory, thoracic and mediastinal disorders   
OROPHARYNGEAL PAIN  1  25/354 (7.06%) 
Skin and subcutaneous tissue disorders   
EXCESSIVE GRANULATION TISSUE  1  51/354 (14.41%) 
Vascular disorders   
ORTHOSTATIC HYPOTENSION  1  28/354 (7.91%) 
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: NCT00335153     History of Changes
Other Study ID Numbers: S187.3.004
2006-005186-18 ( EudraCT Number )
First Submitted: June 8, 2006
First Posted: June 9, 2006
Results First Submitted: January 12, 2015
Results First Posted: January 16, 2015
Last Update Posted: January 16, 2015