Status:
COMPLETED
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Advanced Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief 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.
Detailed Description
Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00660387
Start Date
December 1 2009
End Date
October 1 2011
Last Update
January 16 2015
Active Locations (14)
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1
Site Reference ID/Investigator# 45931
Birmingham, Alabama, United States, 35222
2
Site Reference ID/Investigator# 45910
Fountain Valley, California, United States, 92708
3
Site Reference ID/Investigator# 45925
Oceanside, California, United States, 92056
4
Site Reference ID/Investigator# 45912
Port Charlotte, Florida, United States, 33890