Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease

Study Identifier
M15-737
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Parkinson's Disease
  • Study Drug
  • ABBV-951
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    30+ years

    Protocol Summary

    Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741.

    ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide.

    Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily during the Primary Treatment Period and during the optional Extended Treatment Period.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham - Main /ID# 215597
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Banner Sun Health Research Institute /ID# 215579
    Sun City, Arizona, United States, 85351
    Status
    Not applicable
    Location
    University of Colorado Hospital /ID# 215625
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 215412
    Boca Raton, Florida, United States, 33486
    Status
    Not applicable
    Location
    Indiana Clinical Research Cent /ID# 216490
    Indianapolis, Indiana, United States, 46202
    Status
    Not applicable
    Location
    Univ Kansas Med Ctr /ID# 215624
    Kansas City, Kansas, United States, 66160
    Status
    Not applicable
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