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RECRUITING

NCT06107426

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

450

Start Date

2024-01-24

Completion Date

2029-05

Last Updated

2025-12-24

Healthy Volunteers

Conditions

Parkinson's Disease (PD)

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.

Locations (68)

University of Alabama at Birmingham - Main /ID# 253477

Birmingham, Alabama, United States

Banner Sun Health Research Institute /ID# 253461

Sun City, Arizona, United States

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

Palo Alto, California, United States

Georgetown University Hospital /ID# 259381

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

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

Boca Raton, Florida, United States

University of Florida College of Medicine /ID# 259383

Gainesville, Florida, United States

University of Miami /ID# 259396

Miami, Florida, United States

N1 Research, LLC /ID# 264221

Orlando, Florida, United States

University of South Florida- Neuroscience Institute /ID# 253470

Tampa, Florida, United States

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

Chicago, Illinois, United States

Ochsner Medical Center - Jefferson Highway /ID# 269764

New Orleans, Louisiana, United States

Boston Medical Center Health System /ID# 269765

Brighton, Massachusetts, United States

University of Minnesota - Minneapolis /ID# 268121

Minneapolis, Minnesota, United States

Kansas City VA Medical Center /ID# 253466

Kansas City, Missouri, United States

Cleveland Clinic Lou Ruvo Cent /ID# 259390

Las Vegas, Nevada, United States

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

Commack, New York, United States

Northwell Health /ID# 253469

Lake Success, New York, United States

Novant Health Neurology and Sleep /ID# 259391

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist Medical Center /ID# 259387

Winston-Salem, North Carolina, United States

NeuroCare Center /ID# 259392

Canton, Ohio, United States

The Movement Disorder Clinic of Oklahoma /ID# 253463

Tulsa, Oklahoma, United States

Vanderbilt University Medical Center /ID# 253474

Nashville, Tennessee, United States

Texas Movement Disorder Specialists /ID# 253473

Georgetown, Texas, United States

Univ Texas HSC San Antonio /ID# 259394

San Antonio, Texas, United States

University of Utah /ID# 253471

Salt Lake City, Utah, United States

Evergreenhealth Medical Center /ID# 268120

Kirkland, Washington, United States

Inland Northwest Research /ID# 253460

Spokane, Washington, United States

Westmead Hospital /ID# 259670

Westmead, New South Wales, Australia

The Royal Melbourne Hospital /ID# 259671

Parkville, Victoria, Australia

Medizinische Universitaet Graz /ID# 262774

Graz, Styria, Austria

Medizinische Universitaet Innsbruck /ID# 262775

Innsbruck, Tyrol, Austria

Kepler Universitaetsklinikum GmbH /ID# 262776

Linz, Upper Austria, Austria

Klinik Ottakring /ID# 262773

Vienna, Vienna, Austria

University of Calgary /ID# 262833

Calgary, Alberta, Canada

The Ottawa Hospital - General Campus /ID# 263315

Ottawa, Ontario, Canada

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

Montreal, Quebec, Canada

Centre de Recherche St-Louis /ID# 262746

Québec, Quebec, Canada

Bispebjerg Hospital /ID# 252032

Copenhagen, Capital Region, Denmark

Rigshospitalet Glostrup /ID# 252035

Glostrup Municipality, Capital Region, Denmark

Odense University Hospital /ID# 252036

Odense, Region Syddanmark, Denmark

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

Wolfach, Baden-Wurttemberg, Germany

Klinikum der Universitaet Muenchen Grosshadern /ID# 255574

Munich, Bavaria, Germany

Klinikum Ernst von Bergmann /ID# 252375

Potsdam, Brandenburg, Germany

Klinikum Osnabrueck GmbH /ID# 252275

Osnabrück, Lower Saxony, Germany

Krankenhaus Martha-Maria Halle-Doelau /ID# 260372

Halle, Saxony-Anhalt, Germany

Kliniken Beelitz GmbH /ID# 252665

Beelitz-Heilstätten, Germany

Knappschaftskrankenhaus Bottrop /ID# 252274

Bottrop, Germany

Shaare Zedek Medical Center /ID# 257715

Jerusalem, Jerusalem, Israel

The Chaim Sheba Medical Center /ID# 254823

Ramat Gan, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 254824

Tel Aviv, Tel Aviv, Israel

Rambam Health Care Campus /ID# 260421

Haifa, Israel

Hadassah Medical Center-Hebrew University /ID# 257717

Jerusalem, Israel

Rabin Medical Center. /ID# 257716

Petah Tikva, Israel

Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248

Timișoara, Timiș County, Romania

Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249

Timișoara, Timiș County, Romania

Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308

Brasov, Romania

Spitalul Clinic Colentina /ID# 252250

Bucharest, Romania

Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251

Constanța, Romania

Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 252247

Târgu Mureş, Romania

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

Santiago de Compostela, A Coruna, Spain

Hospital General Universitario de Elche /ID# 254438

Elche, Alicante, Spain

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260921

Majadahonda, Madrid, Spain

Hospital Universitario Virgen de las Nieves /ID# 257588

Granada, Spain

Hospital Clinico San Carlos /ID# 260922

Madrid, Spain

Hospital Universitario Virgen del Rocio /ID# 254437

Seville, Spain

Centrum for neurologi /ID# 252118

Stockholm, Stockholm County, Sweden

Uppsala University Hospital /ID# 252119

Uppsala, Uppsala County, Sweden

Sahlgrenska Universitetssjukhuset /ID# 252115

Gothenburg, Västra Götaland County, Sweden