Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease

Study Identifier
M20-339
CT.gov Identifier
NCT05094050
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Parkinson's Disease
    • Study Drug
  • ABBV-951
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    30+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of idiopathic Parkinson's disease (PD) that is Levodopa-responsive. * Must be taking a minimum of 400 mg/day of levodopa equivalents (LE) and be judged by the investigator to have motor symptoms inadequately controlled by current therapy. * Must have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum daily average of 2.5 hours of "Off" time (with a minimum of 2 hours of "Off" time each day).
    Exclusion Criteria:
    \- History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that in the investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.

    Protocol Summary

    Parkinson's disease (PD) is a neurological condition, which means it affects the brain. This study will evaluate how ABBV-951 is absorbed under the skin of participants with PD when administered to arm, thigh and flank compared to the abdomen.

    ABBV-951 is an investigational drug being developed for the treatment of PD. Study doctors randomly assign participants to 1 of 4 groups, called treatment arms. Each treatment arm receives ABBV-951 administered in a different order in the arm, high, flank and abdomen. Approximately 12 adult participants over 30 years with a diagnosis of PD will be enrolled in approximately 10 sites in the United States.

    Participants will receive continuous (24hours/day) subcutaneous infusion of ABBV-951 for 2 consecutive days for each infusion site (arm, thigh, flank and abdomen), for a total duration of treatment up to 12 days.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will be confined at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Adverse events will be monitored throughout the study.

    Study Locations

    Location
    Status
    Location
    University of Colorado Hospital /ID# 229974
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Georgetown University Hospital /ID# 230224
    Washington D.C., District of Columbia, United States, 20007
    Status
    Not applicable
    Location
    Rush University Medical Center /ID# 229983
    Chicago, Illinois, United States, 60612
    Status
    Not applicable
    Location
    Carolina Phase 1, LLC /ID# 239836
    Raleigh, North Carolina, United States, 27612-8106
    Status
    Not applicable
    Location
    The Movement Disorder Clinic of Oklahoma /ID# 238610
    Tulsa, Oklahoma, United States, 74136-6378
    Status
    Not applicable
    Location
    Vanderbilt University Medical Center /ID# 230255
    Nashville, Tennessee, United States, 37232-0011
    Status
    Not applicable
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