Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

Study Identifier
S187.3.004
CT.gov Identifier
NCT00335153
EudraCT Identifier
2006-005186-18
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
    • 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 with severe motor fluctuations * Recognizable off and on state (motor fluctuations) confirmed by diary
    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 (such as narrow angle glaucoma)

    Protocol Summary

    The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 50065
    Birmingham, Alabama, United States, 35222
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 50059
    Fountain Valley, California, United States, 92708
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 50048
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 50076
    Oceanside, California, United States, 92056
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 50061
    Englewood, Colorado, United States, 80113
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 50079
    Washington D.C., District of Columbia, United States, 20007
    Status
    Not applicable
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