Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects

Study Identifier
S187.3.002
CT.gov Identifier
NCT00660387
EudraCT Identifier
2007-003814-32
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Parkinson's Disease
    • Study Drug
  • Levodopa carbidopa intestinal gel (LCIG)
  • Placebo Gel
  • Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets
  • Placebo (PBO) oral capsules
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    30+ years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 45931
    Birmingham, Alabama, United States, 35222
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45910
    Fountain Valley, California, United States, 92708
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45925
    Oceanside, California, United States, 92056
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45912
    Port Charlotte, Florida, United States, 33890
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45935
    Chicago, Illinois, United States, 60611
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45930
    Lexington, Kentucky, United States, 40536
    Status
    Not applicable
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