Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease

Study Identifier
M20-098
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. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated.

    ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia.

    Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks 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 visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham - Main /ID# 217814
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Usa Mitchell Cancer Institute /ID# 218467
    Mobile, Alabama, United States, 36604
    Status
    Not applicable
    Location
    Xenoscience, Inc /ID# 222515
    Phoenix, Arizona, United States, 85004
    Status
    Not applicable
    Location
    Muhammad Ali Parkinson Center /ID# 218609
    Phoenix, Arizona, United States, 85013-4407
    Status
    Not applicable
    Location
    Movement Disorders Center of Arizona /ID# 218471
    Scottsdale, Arizona, United States, 85258-4582
    Status
    Not applicable
    Location
    Neuro Pain Research Center /ID# 217720
    Fresno, California, United States, 93710
    Status
    Not applicable
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