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

Study Identifier
S187.3.005
CT.gov Identifier
NCT00660673
EudraCT Identifier
2008-001329-33
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Plain Language Summary
Available Language(s): English, Czech, Portuguese (Native), Russian, Thai
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Study Details

Medical Condition
  • Parkinson's Disease
    • Study Drug
  • Levodopa-Carbidopa Intestinal Gel (LCIG)
    • Phase
    Phase 3
    Sex
    N/A
    Age
    30 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * The participant should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG. * For Canada, participants will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study. * The participant must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the participant does not have the capacity to provide informed consent, full informed consent must be obtained from the participant's legally authorized representative. Consenting will be performed according to local regulations.
    Exclusion Criteria:
    * Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the participant's participation in the study.

    Protocol Summary

    The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 \[NCT00360568\] or Study S187.3.004 \[NCT00335153\]).

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham /ID# 49941
    Birmingham, Alabama, United States, 35294
    Status
    Not applicable
    Location
    The Research Center of Southern California /ID# 49928
    Encinitas, California, United States, 92024
    Status
    Not applicable
    Location
    The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 49915
    Fountain Valley, California, United States, 92708
    Status
    Not applicable
    Location
    Universtiy of Southern California /ID# 49913
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    Colorado Neurological Institute /ID# 49927
    Englewood, Colorado, United States, 80113
    Status
    Not applicable
    Location
    Georgetown University Hospital /ID# 49931
    Washington D.C., District of Columbia, United States, 20007
    Status
    Not applicable
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