Phase 3
Completed N=71
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
Advanced Parkinson's Disease
Source: ClinicalTrials.gov NCT00660387 ↗
Enrolled (actual)
71
Serious AEs
16.9%
Results posted
Jan 2015
Primary outcomePrimary: Change From Baseline to Week 12 in Average Daily Normalized "Off" Time — -4.04; -2.14 hours — p=0.0015
Summary
The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Average Daily Normalized "Off" Time |
-4.04; -2.14 | 0.0015 sig |
| SECONDARY Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 12 |
4.11; 2.24 | 0.0059 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12 |
-10.9; -3.9 | 0.0155 sig |
| SECONDARY Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12 |
4.2; 4.6; 2.3; 3.2 | 0.0258 sig |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12 |
-1.8; 1.3 | 0.0086 sig |
| SECONDARY Change From Baseline in UPDRS Part III Score at Week 12 |
-1.5; -2.9 | 0.5020 |
| SECONDARY Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12 |
0.054; -0.016 | 0.0670 |
| SECONDARY Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12 |
-2.8; 1.7 | 0.1501 |
| SECONDARY Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Week 12 |
-0.11; -0.03 | 0.8574 |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12 |
-17.3; -6.8 | 0.0184 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12 |
-12.9; -1.3 | 0.0129 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12 |
-7.1; -4.9 | 0.5246 |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12 |
-8.9; -4.5 | 0.2423 |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12 |
-3.9; -0.1 | 0.2243 |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12 |
-7.3; -3.2 | 0.2407 |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12 |
-9.5; 4.4 | 0.0002 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12 |
-13.5; -10.2 | 0.5213 |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12 |
-0.2; -0.5 | 0.3741 |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12 |
-1.1; 0.1 | 0.0361 sig |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12 |
0.4; 0.8 | 0.3578 |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12 |
-3.6; -2.1 | 0.6088 |
| SECONDARY Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12 |
5.2; -6.3 | 0.0033 sig |
| SECONDARY Employment Impairment (EMP) I Status at Baseline |
10; 8; 6; 3; 2; 1 | — |
| SECONDARY Employment Impairment (EMP) II Status at Week 12 |
10; 5; 6; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
- Levodopa-responsive participants who demonstrate some identifiable 'on response,' established by Investigator observation
- Demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated
Exclusion Criteria
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
- Undergone surgery for the treatment of PD
- Contraindications to levodopa
- Subjects with any neurological deficit that may interfere with the study assessments
Data sourced from ClinicalTrials.gov (NCT00660387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.