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

NCT06107426 | Active Not Recruiting

• 1 other identifier: P22-487
• Study Type: observational
• Target: 427
• Locations: 9 countries
• Sites: 66

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in OFF Time (hours)

  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).

  Up to approximately 3 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Advanced PD, treated with ABBV-951 according to label and local reimbursement regulations, where applicable.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (68)

University of Alabama at Birmingham - Main /ID# 253477

Birmingham, Alabama, 35233, United States

Location

Banner Sun Health Research Institute /ID# 253461

Sun City, Arizona, 85351, United States

Location

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

Palo Alto, California, 94301-2011, United States

Location

Georgetown University Hospital /ID# 259381

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

Location

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

Boca Raton, Florida, 33486, United States

Location

University of Florida College of Medicine /ID# 259383

Gainesville, Florida, 32610, United States

Location

University of Miami /ID# 259396

Miami, Florida, 33138, United States

Location

N1 Research, LLC /ID# 264221

Orlando, Florida, 32825-3769, United States

Location

University of South Florida- Neuroscience Institute /ID# 253470

Tampa, Florida, 33613, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Ochsner Medical Center - Jefferson Highway /ID# 269764

New Orleans, Louisiana, 70121, United States

Location

Boston Medical Center Health System /ID# 269765

Brighton, Massachusetts, 02135, United States

Location

University of Minnesota - Minneapolis /ID# 268121

Minneapolis, Minnesota, 55455-0341, United States

Location

Kansas City VA Medical Center /ID# 253466

Kansas City, Missouri, 64128, United States

Location

Cleveland Clinic Lou Ruvo Cent /ID# 259390

Las Vegas, Nevada, 89106-0100, United States

Location

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

Commack, New York, 11725-6021, United States

Location

Northwell Health /ID# 253469

Lake Success, New York, 11042, United States

Location

Novant Health Neurology and Sleep /ID# 259391

Charlotte, North Carolina, 28207-1100, United States

Location

Atrium Health Wake Forest Baptist Medical Center /ID# 259387

Winston-Salem, North Carolina, 27157, United States

Location

NeuroCare Center /ID# 259392

Canton, Ohio, 44718-2531, United States

Location

The Movement Disorder Clinic of Oklahoma /ID# 253463

Tulsa, Oklahoma, 74136-6378, United States

Location

Vanderbilt University Medical Center /ID# 253474

Nashville, Tennessee, 37232-0011, United States

Location

Texas Movement Disorder Specialists /ID# 253473

Georgetown, Texas, 78628-4126, United States

Location

Univ Texas HSC San Antonio /ID# 259394

San Antonio, Texas, 78229-3901, United States

Location

University of Utah /ID# 253471

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

Location

Evergreenhealth Medical Center /ID# 268120

Kirkland, Washington, 98034, United States

Location

Inland Northwest Research /ID# 253460

Spokane, Washington, 99202-1342, United States

Location

Westmead Hospital /ID# 259670

Westmead, New South Wales, 2145, Australia

Location

The Royal Melbourne Hospital /ID# 259671

Parkville, Victoria, 3050, Australia

Location

Klinik Ottakring /ID# 262773

Vienna, State of Vienna, 1160, Austria

Location

Medizinische Universitaet Graz /ID# 262774

Graz, Styria, 8010, Austria

Location

Medizinische Universitaet Innsbruck /ID# 262775

Innsbruck, Tyrol, 6020, Austria

Location

Kepler Universitaetsklinikum GmbH /ID# 262776

Linz, Upper Austria, 4020, Austria

Location

University of Calgary /ID# 262833

Calgary, Alberta, T2N 4Z6, Canada

Location

The Ottawa Hospital - General Campus /ID# 263315

Ottawa, Ontario, K1H 8L6, Canada

Location

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

Montreal, Quebec, H2X 0A9, Canada

Location

Centre de Recherche St-Louis /ID# 262746

Québec, Quebec, G1W 4R4, Canada

Location

Bispebjerg Hospital /ID# 252032

Copenhagen, Capital Region, 2400, Denmark

Location

Rigshospitalet Glostrup /ID# 252035

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Odense University Hospital /ID# 252036

Odense, Region Syddanmark, 5000, Denmark

Location

Parkinson-Klinik Ortenau GmbH&Co KG /ID# 252376

Wolfach, Baden-Wurttemberg, 77709, Germany

Location

Klinikum der Universitaet Muenchen Grosshadern /ID# 255574

Munich, Bavaria, 81337, Germany

Location

Klinikum Ernst von Bergmann /ID# 252375

Potsdam, Brandenburg, 14467, Germany

Location

Klinikum Osnabrueck GmbH /ID# 252275

Osnabrück, Lower Saxony, 49076, Germany

Location

Krankenhaus Martha-Maria Halle-Doelau /ID# 260372

Halle, Saxony-Anhalt, 06120, Germany

Location

Kliniken Beelitz GmbH /ID# 252665

Beelitz-Heilstätten, 14547, Germany

Location

Knappschaftskrankenhaus Bottrop /ID# 252274

Bottrop, 46242, Germany

Location

Shaare Zedek Medical Center /ID# 257715

Jerusalem, Jerusalem, 91031, Israel

Location

The Chaim Sheba Medical Center /ID# 254823

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 254824

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Rambam Health Care Campus- Haifa /ID# 260421

Haifa, 3525408, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 257717

Jerusalem, 91120, Israel

Location

Rabin Medical Center. /ID# 257716

Petah Tikva, 4941492, Israel

Location

Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248

Timișoara, Timiș County, 300736, Romania

Location

Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249

Timișoara, Timiș County, 300736, Romania

Location

Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308

Brasov, 500326, Romania

Location

Spitalul Clinic Colentina /ID# 252250

Bucharest, 020121, Romania

Location

Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251

Constanța, 900591, Romania

Location

Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 252247

Târgu Mureş, 540136, Romania

Location

Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261402

Santiago de Compostela, A Coruna, 15706, Spain

Location

Hospital General Universitario de Elche /ID# 254438

Elche, Alicante, 03203, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260921

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Virgen de las Nieves /ID# 257588

Granada, 18014, Spain

Location

Hospital Clinico San Carlos /ID# 260922

Madrid, 28040, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 254437

Seville, 41013, Spain

Location

Centrum for neurologi /ID# 252118

Stockholm, Stockholm County, 113 65, Sweden

Location

Uppsala University Hospital /ID# 252119

Uppsala, Uppsala County, 75185, Sweden

Location

Sahlgrenska Universitetssjukhuset /ID# 252115

Gothenburg, Västra Götaland County, 413 46, Sweden

Location

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 30, 2023
• Study Start: January 24, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

AU (4); IL (6); ES (6); CA (4); DK (3); RO (6); SE (3); DE (7); US (27)