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In progress; recruitment closed · registry status

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

A plain-language introduction is being prepared for this study. Open it to read the original description, who can join and how to contact the team.

Learning by observing or collecting information · Study reference: NCT06107426

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Open the official registry record ↗

Follow this study

Following participants

Start (reported actual date)
2024-01-24
Main measurements finished (planned)
2029-05
Study finished (planned)
2029-05

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — active not recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

Real-World Safety and Effectiveness of 24-Hour Foslevodopa/Foscarbidopa in Parkinson's Disease: ROSSINI Study 6-Month Interim Results.
Listed by the registry as research derived from the study · 2026

Participation rules recorded for this study

Age 18 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.
Full study name & original research details

Official study 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)

Short title used by the registry

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

Original description

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 reported: Parkinson's Disease (PD)

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Observational
Interventions
Not reported
Phases
Not reported
Sponsor
AbbVie
Start date reported by registry
2024-01-24 (actual)

Registry updated: 2026-04-27 · Status last verified by the registry submitter: 2026-04

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

No central contact is listed. Check the location contacts or the official registry record.

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University of Alabama at Birmingham - Main /ID# 253477

Birmingham, Alabama, United States

Status not reported

Banner Sun Health Research Institute /ID# 253461

Sun City, Arizona, United States

Status not reported

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

Palo Alto, California, United States

Status not reported

Georgetown University Hospital /ID# 259381

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

Status not reported

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

Boca Raton, Florida, United States

Status not reported

University of Florida College of Medicine /ID# 259383

Gainesville, Florida, United States

Status not reported

University of Miami /ID# 259396

Miami, Florida, United States

Status not reported

N1 Research, LLC /ID# 264221

Orlando, Florida, United States

Status not reported

University of South Florida- Neuroscience Institute /ID# 253470

Tampa, Florida, United States

Status not reported

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

Chicago, Illinois, United States

Status not reported

Ochsner Medical Center - Jefferson Highway /ID# 269764

New Orleans, Louisiana, United States

Status not reported

Boston Medical Center Health System /ID# 269765

Brighton, Massachusetts, United States

Status not reported

University of Minnesota - Minneapolis /ID# 268121

Minneapolis, Minnesota, United States

Status not reported

Kansas City VA Medical Center /ID# 253466

Kansas City, Missouri, United States

Status not reported

Cleveland Clinic Lou Ruvo Cent /ID# 259390

Las Vegas, Nevada, United States

Status not reported

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

Commack, New York, United States

Status not reported

Northwell Health /ID# 253469

Lake Success, New York, United States

Status not reported

Novant Health Neurology and Sleep /ID# 259391

Charlotte, North Carolina, United States

Status not reported

Atrium Health Wake Forest Baptist Medical Center /ID# 259387

Winston-Salem, North Carolina, United States

Status not reported

NeuroCare Center /ID# 259392

Canton, Ohio, United States

Status not reported

The Movement Disorder Clinic of Oklahoma /ID# 253463

Tulsa, Oklahoma, United States

Status not reported

Vanderbilt University Medical Center /ID# 253474

Nashville, Tennessee, United States

Status not reported

Texas Movement Disorder Specialists /ID# 253473

Georgetown, Texas, United States

Status not reported

Univ Texas HSC San Antonio /ID# 259394

San Antonio, Texas, United States

Status not reported

University of Utah /ID# 253471

Salt Lake City, Utah, United States

Status not reported

Evergreenhealth Medical Center /ID# 268120

Kirkland, Washington, United States

Status not reported

Inland Northwest Research /ID# 253460

Spokane, Washington, United States

Status not reported

Westmead Hospital /ID# 259670

Westmead, New South Wales, Australia

Status not reported

The Royal Melbourne Hospital /ID# 259671

Parkville, Victoria, Australia

Status not reported

Klinik Ottakring /ID# 262773

Vienna, State of Vienna, Austria

Status not reported

Medizinische Universitaet Graz /ID# 262774

Graz, Styria, Austria

Status not reported

Medizinische Universitaet Innsbruck /ID# 262775

Innsbruck, Tyrol, Austria

Status not reported

Kepler Universitaetsklinikum GmbH /ID# 262776

Linz, Upper Austria, Austria

Status not reported

University of Calgary /ID# 262833

Calgary, Alberta, Canada

Status not reported

The Ottawa Hospital - General Campus /ID# 263315

Ottawa, Ontario, Canada

Status not reported

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

Montreal, Quebec, Canada

Status not reported

Centre de Recherche St-Louis /ID# 262746

Québec, Quebec, Canada

Status not reported

Bispebjerg Hospital /ID# 252032

Copenhagen, Capital Region, Denmark

Status not reported

Rigshospitalet Glostrup /ID# 252035

Glostrup Municipality, Capital Region, Denmark

Status not reported

Odense University Hospital /ID# 252036

Odense, Region Syddanmark, Denmark

Status not reported

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

Wolfach, Baden-Wurttemberg, Germany

Status not reported

Klinikum der Universitaet Muenchen Grosshadern /ID# 255574

Munich, Bavaria, Germany

Status not reported

Klinikum Ernst von Bergmann /ID# 252375

Potsdam, Brandenburg, Germany

Status not reported

Klinikum Osnabrueck GmbH /ID# 252275

Osnabrück, Lower Saxony, Germany

Status not reported

Krankenhaus Martha-Maria Halle-Doelau /ID# 260372

Halle, Saxony-Anhalt, Germany

Status not reported

Kliniken Beelitz GmbH /ID# 252665

Beelitz-Heilstätten, Germany

Status not reported

Knappschaftskrankenhaus Bottrop /ID# 252274

Bottrop, Germany

Status not reported

Shaare Zedek Medical Center /ID# 257715

Jerusalem, Jerusalem, Israel

Status not reported

The Chaim Sheba Medical Center /ID# 254823

Ramat Gan, Tel Aviv, Israel

Status not reported

Tel Aviv Sourasky Medical Center /ID# 254824

Tel Aviv, Tel Aviv, Israel

Status not reported

Rambam Health Care Campus- Haifa /ID# 260421

Haifa, Israel

Status not reported

Hadassah Medical Center-Hebrew University /ID# 257717

Jerusalem, Israel

Status not reported

Rabin Medical Center. /ID# 257716

Petah Tikva, Israel

Status not reported

Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248

Timișoara, Timiș County, Romania

Status not reported

Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249

Timișoara, Timiș County, Romania

Status not reported

Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308

Brasov, Romania

Status not reported

Spitalul Clinic Colentina /ID# 252250

Bucharest, Romania

Status not reported

Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251

Constanța, Romania

Status not reported

Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 252247

Târgu Mureş, Romania

Status not reported

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

Santiago de Compostela, A Coruna, Spain

Status not reported

Hospital General Universitario de Elche /ID# 254438

Elche, Alicante, Spain

Status not reported

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260921

Majadahonda, Madrid, Spain

Status not reported

Hospital Universitario Virgen de las Nieves /ID# 257588

Granada, Spain

Status not reported

Hospital Clinico San Carlos /ID# 260922

Madrid, Spain

Status not reported

Hospital Universitario Virgen del Rocio /ID# 254437

Seville, Spain

Status not reported

Centrum for neurologi /ID# 252118

Stockholm, Stockholm County, Sweden

Status not reported

Uppsala University Hospital /ID# 252119

Uppsala, Uppsala County, Sweden

Status not reported

Sahlgrenska Universitetssjukhuset /ID# 252115

Gothenburg, Västra Götaland County, Sweden

Status not reported

Facility not reported

United States

Status not reported

Facility not reported

Australia

Status not reported

Facility not reported

Austria

Status not reported

Facility not reported

Canada

Status not reported

Facility not reported

Denmark

Status not reported

Facility not reported

Germany

Status not reported

Facility not reported

Israel

Status not reported

Facility not reported

Romania

Status not reported

Facility not reported

Spain

Status not reported

Facility not reported

Sweden

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.