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Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive 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: NCT00357994
Recruitment Status : Completed
First Posted : July 28, 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 Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Advanced Parkinson's Disease
Interventions Drug: Levodopa carbidopa intestinal gel (LCIG)
Drug: Placebo gel
Drug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets
Drug: Placebo (PBO) oral capsules
Device: CADD-Legacy® 1400 ambulatory infusion pump
Device: PEG tube
Device: J-tube
Enrollment 36
Recruitment Details  
Pre-assignment Details Studies S187.3.001 (NCT00357994) and S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. All study information and results presented reflect the study data and analyses for the two studies combined.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG. Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Period Title: Overall Study
Started 37 34
Completed 35 31
Not Completed 2 3
Reason Not Completed
Adverse Event             1             2
Lack of Efficacy             0             1
Protocol Violation             1             0
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules Total
Hide Arm/Group Description Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG. Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo. Total of all reporting groups
Overall Number of Baseline Participants 37 34 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 34 participants 71 participants
63.7  (9.5) 65.1  (6.8) 64.4  (8.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 34 participants 71 participants
<65 years 21 15 36
>=65 years 16 19 35
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 34 participants 71 participants
Female
13
  35.1%
12
  35.3%
25
  35.2%
Male
24
  64.9%
22
  64.7%
46
  64.8%
1.Primary Outcome
Title Change From Baseline to Week 12 in Average Daily Normalized "Off" Time
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 35 31
Least Squares Mean (Standard Error)
Unit of Measure: hours
-4.04  (0.65) -2.14  (0.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0015
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -1.91
Confidence Interval (2-Sided) 95%
-3.05 to -0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.57
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 35 31
Least Squares Mean (Standard Error)
Unit of Measure: hours
4.11  (0.75) 2.24  (0.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0059
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value 1.86
Confidence Interval (2-Sided) 95%
0.56 to 3.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.65
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-10.9  (3.3) -3.9  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0155
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -7.0
Confidence Interval (2-Sided) 95%
-12.6 to -1.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
CGI-S at Baseline 4.2  (0.7) 4.6  (0.8)
CGI-I at Week 12 2.3  (1.2) 3.2  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0258
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.4 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.8  (1.3) 1.3  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0086
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-5.3 to -0.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in UPDRS Part III Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.5  (2.4) -2.9  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5020
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-2.8 to 5.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.1
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 32
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.054  (0.043) -0.016  (0.043)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0670
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value 0.070
Confidence Interval (2-Sided) 95%
-0.005 to 0.146
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.038
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 23 23
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.8  (3.7) 1.7  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1501
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treament Difference (LS Mean)
Estimated Value -4.5
Confidence Interval (2-Sided) 95%
-10.7 to 1.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.1
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Week 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. 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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 35 31
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.11  (0.52) -0.03  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8574
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.98 to 0.82
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.45
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-17.3  (5.0) -6.8  (4.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0184
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -10.4
Confidence Interval (2-Sided) 95%
-19.1 to -1.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.3
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-12.9  (5.3) -1.3  (5.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0129
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -11.6
Confidence Interval (2-Sided) 95%
-20.6 to -2.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.5
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 35 32
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-7.1  (4.0) -4.9  (4.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5246
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-9.0 to 4.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.4
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.9  (4.4) -4.5  (4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2423
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -4.5
Confidence Interval (2-Sided) 95%
-12.0 to 3.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.8
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 32
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.9  (3.5) -0.1  (3.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2243
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-9.9 to 2.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.1
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-7.3  (4.0) -3.2  (3.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2407
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -4.0
Confidence Interval (2-Sided) 95%
-10.8 to 2.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.4
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.5  (4.1) 4.4  (4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -13.8
Confidence Interval (2-Sided) 95%
-20.8 to -6.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.5
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-13.5  (6.1) -10.2  (6.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5213
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -3.3
Confidence Interval (2-Sided) 95%
-13.6 to 6.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.1
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.2  (0.4) -0.5  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3741
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.4 to 0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.1  (0.7) 0.1  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0361
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-2.4 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12
Hide Description The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. Questions 32, 33, and 34 on UPDRS Part IV were totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.4  (0.5) 0.8  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3578
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.1 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.4
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12
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 no disability.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.6  (3.4) -2.1  (3.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6088
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-7.4 to 4.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.9
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12
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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 36 32
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.2  (4.3) -6.3  (4.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCIG + Placebo Capsules, Placebo Gel + Levodopa-Carbidopa Capsules
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments [Not Specified]
Method ANCOVA
Comments Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.
Method of Estimation Estimation Parameter Treatment Difference (LS Mean)
Estimated Value 11.4
Confidence Interval (2-Sided) 95%
4.0 to 18.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.7
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Employment Impairment (EMP) I Status at Baseline
Hide Description The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 35 31
Measure Type: Number
Unit of Measure: participants
Paid Employment (PE)=Yes 10 8
PE=Yes, 100% of Past 4 Weeks 6 3
PE=Yes, 75% of Past 4 Weeks 2 1
PE=Yes, 50% of Past 4 Weeks 0 2
PE=Yes, 25% of Past 4 Weeks 1 1
PE=Yes, Other % of Past 4 Weeks 1 1
PE=No 25 23
Someone Else Runs the Household (SRH)=Yes 24 25
SRH=Yes, 100% of Time per Week 15 13
SRH=Yes, 75% of Time per Week 3 4
SRH=Yes, 50% of Time per Week 3 5
SRH=Yes, 25% of Time per Week 2 1
SRH=Yes, Other % of Time per Week 1 2
SRH=No 11 6
Are You Retired (R)=Yes 24 23
R=Yes, Old Age Pensioner 8 8
R=Yes, Premature Due to PD 13 12
R=Yes, Premature Due to Other Condition 1 1
R=Yes, Other Reason 2 2
R=No 11 8
24.Secondary Outcome
Title Employment Impairment (EMP) II Status at Week 12
Hide Description The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?) The retirement question (from EMP I) is excluded from the EMP II instrument.
Time Frame Week 12 (or early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description:
Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Number of Participants Analyzed 35 31
Measure Type: Number
Unit of Measure: participants
Paid Employment (PE)=Yes 10 5
PE=Yes, 100% of Past 4 Weeks 6 1
PE=Yes, 75% of Past 4 Weeks 1 1
PE=Yes, 50% of Past 4 Weeks 1 2
PE=Yes, 25% of Past 4 Weeks 0 1
PE=Yes, Other % of Past 4 Weeks 2 0
PE=No 25 26
Someone Else Runs the Household (SRH)=Yes 22 24
SRH=Yes, 100% of Time per Week 13 12
SRH=Yes, 75% of Time per Week 5 4
SRH=Yes, 50% of Time per Week 0 4
SRH=Yes, 25% of Time per Week 2 2
SRH=Yes, Other % of Time per Week 2 2
SRH=No 13 7
Time Frame From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days.
Adverse Event Reporting Description Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
 
Arm/Group Title LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Hide Arm/Group Description Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG. Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
All-Cause Mortality
LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LCIG + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Affected / at Risk (%) Affected / at Risk (%)
Total   5/37 (13.51%)   7/34 (20.59%) 
Blood and lymphatic system disorders     
NEUTROPENIA  1  0/37 (0.00%)  1/34 (2.94%) 
Cardiac disorders     
ATRIAL FIBRILLATION  1  1/37 (2.70%)  0/34 (0.00%) 
ATRIAL FLUTTER  1  1/37 (2.70%)  0/34 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  0/37 (0.00%)  1/34 (2.94%) 
PERITONITIS  1  0/37 (0.00%)  1/34 (2.94%) 
PNEUMOPERITONEUM  1  1/37 (2.70%)  0/34 (0.00%) 
General disorders     
COMPLICATION OF DEVICE INSERTION  1  1/37 (2.70%)  1/34 (2.94%) 
Infections and infestations     
CATHETER SITE CELLULITIS  1  1/37 (2.70%)  0/34 (0.00%) 
PNEUMONIA  1  0/37 (0.00%)  2/34 (5.88%) 
Injury, poisoning and procedural complications     
FEMUR FRACTURE  1  0/37 (0.00%)  1/34 (2.94%) 
POST PROCEDURAL COMPLICATION  1  0/37 (0.00%)  1/34 (2.94%) 
Investigations     
BODY TEMPERATURE INCREASED  1  0/37 (0.00%)  1/34 (2.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
SPINAL HAEMANGIOMA  1  0/37 (0.00%)  1/34 (2.94%) 
Nervous system disorders     
DEPRESSED LEVEL OF CONSCIOUSNESS  1  0/37 (0.00%)  1/34 (2.94%) 
DYSKINESIA  1  1/37 (2.70%)  0/34 (0.00%) 
HYPERSOMNIA  1  1/37 (2.70%)  0/34 (0.00%) 
PARKINSON'S DISEASE  1  0/37 (0.00%)  1/34 (2.94%) 
Psychiatric disorders     
CONFUSIONAL STATE  1  2/37 (5.41%)  0/34 (0.00%) 
DELUSION  1  1/37 (2.70%)  0/34 (0.00%) 
HALLUCINATION  1  1/37 (2.70%)  0/34 (0.00%) 
MENTAL STATUS CHANGES  1  0/37 (0.00%)  1/34 (2.94%) 
MUTISM  1  1/37 (2.70%)  0/34 (0.00%) 
PSYCHOTIC DISORDER  1  1/37 (2.70%)  1/34 (2.94%) 
Renal and urinary disorders     
RENAL CYST  1  0/37 (0.00%)  1/34 (2.94%) 
Vascular disorders     
ORTHOSTATIC HYPOTENSION  1  0/37 (0.00%)  1/34 (2.94%) 
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 + Placebo Capsules Placebo Gel + Levodopa-Carbidopa Capsules
Affected / at Risk (%) Affected / at Risk (%)
Total   35/37 (94.59%)   34/34 (100.00%) 
Gastrointestinal disorders     
ABDOMINAL DISCOMFORT  1  1/37 (2.70%)  3/34 (8.82%) 
ABDOMINAL DISTENSION  1  2/37 (5.41%)  1/34 (2.94%) 
ABDOMINAL PAIN  1  19/37 (51.35%)  10/34 (29.41%) 
ABDOMINAL PAIN UPPER  1  1/37 (2.70%)  2/34 (5.88%) 
CONSTIPATION  1  8/37 (21.62%)  7/34 (20.59%) 
DIARRHOEA  1  2/37 (5.41%)  1/34 (2.94%) 
DYSPEPSIA  1  2/37 (5.41%)  1/34 (2.94%) 
FLATULENCE  1  6/37 (16.22%)  4/34 (11.76%) 
GASTRITIS  1  1/37 (2.70%)  3/34 (8.82%) 
HIATUS HERNIA  1  3/37 (8.11%)  2/34 (5.88%) 
NAUSEA  1  11/37 (29.73%)  7/34 (20.59%) 
PNEUMOPERITONEUM  1  3/37 (8.11%)  1/34 (2.94%) 
REFLUX OESOPHAGITIS  1  0/37 (0.00%)  2/34 (5.88%) 
VOMITING  1  2/37 (5.41%)  4/34 (11.76%) 
General disorders     
COMPLICATION OF DEVICE INSERTION  1  20/37 (54.05%)  14/34 (41.18%) 
FATIGUE  1  0/37 (0.00%)  2/34 (5.88%) 
NON-CARDIAC CHEST PAIN  1  0/37 (0.00%)  2/34 (5.88%) 
OEDEMA PERIPHERAL  1  3/37 (8.11%)  0/34 (0.00%) 
PYREXIA  1  2/37 (5.41%)  0/34 (0.00%) 
Infections and infestations     
POSTOPERATIVE WOUND INFECTION  1  4/37 (10.81%)  8/34 (23.53%) 
UPPER RESPIRATORY TRACT INFECTION  1  3/37 (8.11%)  0/34 (0.00%) 
URINARY TRACT INFECTION  1  0/37 (0.00%)  4/34 (11.76%) 
Injury, poisoning and procedural complications     
FALL  1  4/37 (10.81%)  4/34 (11.76%) 
INCISION SITE ERYTHEMA  1  7/37 (18.92%)  4/34 (11.76%) 
POST PROCEDURAL DISCHARGE  1  4/37 (10.81%)  3/34 (8.82%) 
POSTOPERATIVE ILEUS  1  2/37 (5.41%)  0/34 (0.00%) 
PROCEDURAL PAIN  1  11/37 (29.73%)  12/34 (35.29%) 
PROCEDURAL SITE REACTION  1  2/37 (5.41%)  2/34 (5.88%) 
Investigations     
BACTERIAL TEST POSITIVE  1  2/37 (5.41%)  0/34 (0.00%) 
VITAMIN B6 DECREASED  1  1/37 (2.70%)  2/34 (5.88%) 
WEIGHT DECREASED  1  0/37 (0.00%)  2/34 (5.88%) 
WHITE BLOOD CELLS URINE POSITIVE  1  2/37 (5.41%)  0/34 (0.00%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  0/37 (0.00%)  4/34 (11.76%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  2/37 (5.41%)  3/34 (8.82%) 
MUSCULOSKELETAL PAIN  1  1/37 (2.70%)  5/34 (14.71%) 
PAIN IN EXTREMITY  1  2/37 (5.41%)  2/34 (5.88%) 
Nervous system disorders     
DIZZINESS  1  3/37 (8.11%)  2/34 (5.88%) 
DYSKINESIA  1  4/37 (10.81%)  4/34 (11.76%) 
FREEZING PHENOMENON  1  1/37 (2.70%)  2/34 (5.88%) 
HEADACHE  1  3/37 (8.11%)  4/34 (11.76%) 
Psychiatric disorders     
ANXIETY  1  3/37 (8.11%)  1/34 (2.94%) 
DEPRESSION  1  4/37 (10.81%)  1/34 (2.94%) 
INSOMNIA  1  4/37 (10.81%)  4/34 (11.76%) 
SLEEP DISORDER  1  2/37 (5.41%)  0/34 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
ATELECTASIS  1  3/37 (8.11%)  0/34 (0.00%) 
OROPHARYNGEAL PAIN  1  3/37 (8.11%)  0/34 (0.00%) 
Skin and subcutaneous tissue disorders     
EXCESSIVE GRANULATION TISSUE  1  2/37 (5.41%)  0/34 (0.00%) 
RASH  1  2/37 (5.41%)  0/34 (0.00%) 
Vascular disorders     
HYPERTENSION  1  3/37 (8.11%)  0/34 (0.00%) 
ORTHOSTATIC HYPOTENSION  1  5/37 (13.51%)  7/34 (20.59%) 
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: NCT00357994     History of Changes
Other Study ID Numbers: S187.3.001
2006-000577-29 ( EudraCT Number )
First Submitted: July 27, 2006
First Posted: July 28, 2006
Results First Submitted: January 12, 2015
Results First Posted: January 16, 2015
Last Update Posted: January 16, 2015