Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

Study Identifier
S187.3.003
CT.gov Identifier
NCT00360568
EudraCT Identifier
2006-000578-53
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
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    30+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Idiopathic Parkinson's disease (PD) according to United Kingdon Parkinson's Disease Society (UKPDS) Brain Bank Criteria * Levodopa-responsive with severe motor fluctuations * Completion of protocol S187.3.001 (NCT00357994) or S187.3.002 (NCT00660387) and continue to meet the inclusion criteria for the preceding study
    Exclusion Criteria:
    * Patients with medically relevant abnormal findings (labs, electrocardiogram \[ECG\], physical examination, adverse events, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (Week 12) of Study S187.3.001 (NCT00357994) or Study S187.3.002 (NCT00660387)

    Protocol Summary

    Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 45869
    Birmingham, Alabama, United States, 35222
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45834
    Fountain Valley, California, United States, 92708
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45854
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45856
    Oceanside, California, United States, 92056
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45859
    Washington D.C., District of Columbia, United States, 20007
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45857
    Bradenton, Florida, United States, 34205
    Status
    Not applicable
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