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

Study Identifier
S187.3.001
CT.gov Identifier
NCT00357994
EudraCT Identifier
2006-000577-29
EUCTIS ID
Not available
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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# 45719
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45718
    Englewood, Colorado, United States, 80113
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45722
    Washington D.C., District of Columbia, United States, 20007
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45721
    Bradenton, Florida, United States, 34205
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45705
    Gainesville, Florida, United States, 32610
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45740
    Baltimore, Maryland, United States, 21201
    Status
    Not applicable
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