A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

Study Identifier
M15-741
CT.gov Identifier
NCT03781167
EudraCT Identifier
2018-002144-85
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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Plain Language Summary
Available Language(s): English, Danish, Dutch, German, Japanese, Spanish
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Parkinson's Disease
    • Study Drug
  • ABBV-951
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    30+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive * Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day
    Exclusion Criteria:
    * Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study * Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason

    Protocol Summary

    The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).

    This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham - Main /ID# 207996
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Banner Sun Health Res Inst /ID# 208811
    Sun City, Arizona, United States, 85351
    Status
    Not applicable
    Location
    The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216126
    Fountain Valley, California, United States, 92708
    Status
    Not applicable
    Location
    University of Colorado Hospital /ID# 207968
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 207677
    Boca Raton, Florida, United States, 33486
    Status
    Not applicable
    Location
    Northwestern University Feinberg School of Medicine /ID# 208812
    Chicago, Illinois, United States, 60611-2927
    Status
    Not applicable
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