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ROSSINI: Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease

Sponsor
AbbVie (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06107426
Collaborator
(none)
450
Enrollment
65.4
Anticipated Duration (Months)

Study Details

Study Description

Brief 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 evaluate how effective ABBV-951 is in treating adult participants with advanced PD in real world setting.

ABBV-951 (foslevodopa/foscarbidopa) is an approved drug for the treatment of Parkinson's Disease. Approximately 450 adult participants with PD (300 participants new to ABBV-951, up to 150 participants transitioning from open-label extension study) will be enrolled across approximately 60 sites. Decision to treat with ABBV-951 (or continue the treatment in Cohort

  1. will be made by the doctor prior to any decision to approach the participant to participate in this study.

All participants will receive subcutaneous infusion of ABBV-951 for approximately 3 years.

Participants will attend regular clinic visits during the course of the study. The effect of the treatment will be checked by medical assessments, and completing questionnaires.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    450 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Global Real-World Evidence Study on the Long-term Effectiveness of ABBV-951 in Advanced Parkinson´s Disease in Routine Clinical Practice (ROSSINI: Real-world Outcomes With continuouS Subcutaneous Levodopa INfusIon)
    Anticipated Study Start Date :
    Dec 1, 2023
    Anticipated Primary Completion Date :
    Feb 16, 2028
    Anticipated Study Completion Date :
    May 13, 2029

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort A: ABBV-951

    Participants naïve to ABBV-951 will receive ABBV-951 as prescribed by their physician according to the local label.
    Cohort B: ABBV-951

    Participants transitioning from the Open-Label Extension studies M15-737 and M20-098 will continue to receive ABBV-951.

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in OFF Time (hours) [Up to approximately 3 years]

      The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM).

    Eligibility Criteria

    Criteria

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

    • Eligibility for ABBV-951 therapy in accordance with the approved local label in the participating country and local reimbursement regulations, if applicable.

    • Diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD).

    • Participant must be either:

    • Cohort A: Naïve to ABBV-951

    • Cohort B: Pre-treated with ABBV-951, specifically, participants of Open-Label Extension Studies M15-737 and M20-098 who completed these studies without significant protocol deviations and who did not experience an adverse event (AE) that in the investigator's opinion may indicate an unacceptable safety risk.

    • Decision to treat with ABBV-951 (or continue the treatment in Cohort B) made by the clinician prior to any decision to approach the participant to participate in this study.

    • Prior to any study-related procedures being performed, the participant, or legal authorized representative (LAR) has voluntarily signed an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) according to national regulations after the study has been explained and the participant has had the opportunity to have questions answered.

    Exclusion Criteria:

    • Any condition included in the contraindications section of the approved local ABBV-951 label in the participating country.

    • Mini-Mental State Examination (MMSE) score < 24.

    • If the participant has a score of 19-23, he/she can be included if based on the investigator´s judgment the participant is able to handle the therapy and follow the study procedures with the help of a permanent caregiver.

    • Participation in a concurrent interventional clinical trial from enrollment and throughout the study.

    • History of significant skin conditions or disorders per investigator´s judgment. In case of temporary affections like recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations, the participant should not be included if the investigator considers these as interfering with the infusion of study drug or with study assessments.

    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:
    NCT06107426
    Other Study ID Numbers:
    • P22-487
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 30, 2023
    Last Verified:
    Oct 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
    Advance Parkinson's Disease
    ABBV-951
    Foslevodopa/foscarbidopa
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Oct 30, 2023