Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease
NCT ID: NCT06107426
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2024-01-24
2029-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A: ABBV-951
Participants naïve to ABBV-951 will receive ABBV-951 as prescribed by their physician according to the local label.
No interventions assigned to this group
Cohort B: ABBV-951
Participants transitioning from the Open-Label Extension studies M15-737 and M20-098 will continue to receive ABBV-951.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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P22-487
Identifier Type: -
Identifier Source: org_study_id