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An Observational Study of Subcutaneous Infusion of ABBV-951 to Assess Change in Disease Activity and Adverse Events In Adult Japanese Participants With Advanced Parkinson's Disease

Sponsor
AbbVie (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05916157
Collaborator
(none)
250
Enrollment
35.8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Parkinson's disease (PD) is a neurological condition, which affects the brain. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to assess how safe and effective ABBV-951 is in treating participants with Parkinson's disease in real world setting.

ABBV-951 is an approved drug being developed for the treatment of PD in Japan. Approximately 250 adult participants over 15 years with a diagnosis of PD who are prescribed ABBV-951 by their physicians will be enrolled in this study across Japan.

Participants will receive ABBV-951 as prescribed their physician and followed for 52 weeks.

There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Post-marketing Observational Study for ABBV-951 in Patients Diagnosed With Advanced Parkinson's Disease (aPD)
    Anticipated Study Start Date :
    Jul 12, 2023
    Anticipated Primary Completion Date :
    Jul 5, 2026
    Anticipated Study Completion Date :
    Jul 5, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    ABBV-951

    Participants will receive ABBV-951 as prescribed by their physician.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Experiencing Infusion Site Infections [Up to 52 Weeks]

      Incidence percentage of participants with infusion site infections following the commencement of ABBV-951 will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosed with advanced Parkinson's disease (aPD).

    • Prescribed ABBV-951 as physicians' decision according to the approved label for treatment of aPD.

    • Given informed consent (or by her/his legal representative, if it's a requirement from the participating hospital/clinic) for participating this study.

    Exclusion Criteria:

    • Prior treatment with ABBV-951 for PD.

    • Currently participating in interventional clinical trials.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05916157
    Other Study ID Numbers:
    • P23-529
    First Posted:
    Jun 23, 2023
    Last Update Posted:
    Jun 23, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Parkinson's Disease (PD)
    advanced Parkinson's disease (aPD)
    ABBV-951
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Jun 23, 2023