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

Sponsor:

AbbVie

Code:

NCT06107426

Conditions

Parkinson's Disease (PD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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. The main ROSSINI study will have 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 B) will be made by the doctor prior to any decision to approach the participant to participate in this study. There will be a sub-study that will enroll 40 naïve participants who initiated Foslevodopa/Foscarbidopa treatment for the first time (Cohort A of the ROSSINI parent study only) from 6 to 15 centers in the United States, Germany and Spain.

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.

Conditions

Parkinson's Disease (PD)

Study ID

NCT06107426

Start date

Jan 24, 2024

Status verified date

Dec, 2025

Completion date

May, 2029

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Country Specific Sub-Study

Participants located in the United States, Germany and Spain, that participated in Cohort A, will participate in a single initial interview and those who continue on the treatment after 6 months will participate in a follow-up interview to explore the longitudinal impact of the treatment. Those participants who discontinue prior to the 6 months time point will engage in a discontinuation interview to understand reasons for their discontinuation of treatment.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lars Bergmann

+49(0)170 4538568 lars.bergmann@abbvie.com

Locations

University of Alabama at Birmingham - Main /ID# 253477

Recruiting

Birmingham, Alabama, United States, 35233

Banner Sun Health Research Institute /ID# 253461

Recruiting

Sun City, Arizona, United States, 85351

Parkinson's Research Centers of America - Palo Alto /ID# 264703

Recruiting

Palo Alto, California, United States, 94301-2011

Georgetown University Hospital /ID# 259381

Recruiting

Washington D.C., District of Columbia, United States, 20007

Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465

Recruiting

Boca Raton, Florida, United States, 33486

University of Florida College of Medicine /ID# 259383

Recruiting

Gainesville, Florida, United States, 32610

University of Miami /ID# 259396

Recruiting

Miami, Florida, United States, 33138

N1 Research, LLC /ID# 264221

Recruiting

Orlando, Florida, United States, 32825-3769

University of South Florida- Neuroscience Institute /ID# 253470

Recruiting

Tampa, Florida, United States, 33613

Northwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977

Recruiting

Chicago, Illinois, United States, 60611

Ochsner Medical Center - Jefferson Highway /ID# 269764

Recruiting

New Orleans, Louisiana, United States, 70121

Boston Medical Center Health System /ID# 269765

Recruiting

Brighton, Massachusetts, United States, 02135

University of Minnesota - Minneapolis /ID# 268121

Recruiting

Minneapolis, Minnesota, United States, 55455-0341

Kansas City VA Medical Center /ID# 253466

Recruiting

Kansas City, Missouri, United States, 64128

Cleveland Clinic Lou Ruvo Cent /ID# 259390

Recruiting

Las Vegas, Nevada, United States, 89106-0100

David L. Kreitzman, MD, PC /ID# 259397

Recruiting

Commack, New York, United States, 11725-6021

Northwell Health /ID# 253469

Recruiting

Lake Success, New York, United States, 11042

Novant Health Neurology and Sleep /ID# 259391

Recruiting

Charlotte, North Carolina, United States, 28207-1100

Atrium Health Wake Forest Baptist Medical Center /ID# 259387

Recruiting

Winston-Salem, North Carolina, United States, 27157

NeuroCare Center /ID# 259392

Recruiting

Canton, Ohio, United States, 44718-2531

The Movement Disorder Clinic of Oklahoma /ID# 253463

Recruiting

Tulsa, Oklahoma, United States, 74136-6378

Vanderbilt University Medical Center /ID# 253474

Recruiting

Nashville, Tennessee, United States, 37232-0011

Texas Movement Disorder Specialists /ID# 253473

Recruiting

Georgetown, Texas, United States, 78628-4126

Univ Texas HSC San Antonio /ID# 259394

Recruiting

San Antonio, Texas, United States, 78229-3901

University of Utah /ID# 253471

Recruiting

Salt Lake City, Utah, United States, 84112-5500

Evergreenhealth Medical Center /ID# 268120

Recruiting

Kirkland, Washington, United States, 98034

Inland Northwest Research /ID# 253460

Recruiting

Spokane, Washington, United States, 99202-1342

University of Calgary /ID# 262833

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

The Ottawa Hospital - General Campus /ID# 263315

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269689

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Centre de Recherche St-Louis /ID# 262746

Recruiting

Québec, Quebec, Canada, G1W 4R4

More Information

Sponsor

AbbVie

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

Parkinson's Disease
Advance Parkinson's Disease
ABBV-951
Foslevodopa/foscarbidopa

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by AbbVie on 2025-12-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.