NCT06107426Active, not recruiting
Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease
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)
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 427 (actual)
- First submitted
- 25 Oct 2023
- Start date
- 24 Jan 2024
- Primary completion date
- May 2029
- Lead sponsor
- AbbVie
- Diseases
- Parkinson disease
- NCT number
- NCT06107426
What you commit to
- Study type: Observational
- Participants enrolled: 427
- From 24 Jan 2024 to the primary completion date, May 2029
- 68 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any condition included in the contraindications section of the approved local ABBV-951 label in the participating country.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (68)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Graz /ID# 262774 Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Medizinische Universitaet Innsbruck /ID# 262775 Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| Kepler Universitaetsklinikum GmbH /ID# 262776 Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Klinik Ottakring /ID# 262773 Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| The Royal Melbourne Hospital /ID# 259671 Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Westmead Hospital /ID# 259670 Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| University of Calgary /ID# 262833 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269689 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Ottawa Hospital - General Campus /ID# 263315 Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Centre de Recherche St-Louis /ID# 262746 Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Kliniken Beelitz GmbH /ID# 252665 Coordinator of this site? Confirm its status | Beelitz-Heilstätten | Germany | Unknown status |
| Knappschaftskrankenhaus Bottrop /ID# 252274 Coordinator of this site? Confirm its status | Bottrop | Germany | Unknown status |
| Krankenhaus Martha-Maria Halle-Doelau /ID# 260372 Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Klinikum der Universitaet Muenchen Grosshadern /ID# 255574 Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Klinikum Osnabrueck GmbH /ID# 252275 Coordinator of this site? Confirm its status | Osnabrück | Germany | Unknown status |
| Klinikum Ernst von Bergmann /ID# 252375 Coordinator of this site? Confirm its status | Potsdam | Germany | Unknown status |
| Parkinson-Klinik Ortenau GmbH&Co KG /ID# 252376 Coordinator of this site? Confirm its status | Wolfach | Germany | Unknown status |
| Bispebjerg Hospital /ID# 252032 Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Rigshospitalet Glostrup /ID# 252035 Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
| Odense University Hospital /ID# 252036 Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Hospital General Universitario de Elche /ID# 254438 Coordinator of this site? Confirm its status | Elche | Spain | Unknown status |
| Hospital Universitario Virgen de las Nieves /ID# 257588 Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Clinico San Carlos /ID# 260922 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260921 Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261402 Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio /ID# 254437 Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Rambam Health Care Campus- Haifa /ID# 260421 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center /ID# 257715 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Hadassah Medical Center-Hebrew University /ID# 257717 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center. /ID# 257716 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| The Chaim Sheba Medical Center /ID# 254823 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center /ID# 254824 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308 Coordinator of this site? Confirm its status | Brasov | Romania | Unknown status |
| Spitalul Clinic Colentina /ID# 252250 Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251 Coordinator of this site? Confirm its status | Constanța | Romania | Unknown status |
| Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 252247 Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Unknown status |
| Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248 Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
| Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249 Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
| Sahlgrenska Universitetssjukhuset /ID# 252115 Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Centrum for neurologi /ID# 252118 Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Uppsala University Hospital /ID# 252119 Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
| University of Alabama at Birmingham - Main /ID# 253477 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465 Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Boston Medical Center Health System /ID# 269765 Coordinator of this site? Confirm its status | Brighton | United States | Unknown status |
| NeuroCare Center /ID# 259392 Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Novant Health Neurology and Sleep /ID# 259391 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Northwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| David L. Kreitzman, MD, PC /ID# 259397 Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| University of Florida College of Medicine /ID# 259383 Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Texas Movement Disorder Specialists /ID# 253473 Coordinator of this site? Confirm its status | Georgetown | United States | Unknown status |
| Kansas City VA Medical Center /ID# 253466 Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Evergreenhealth Medical Center /ID# 268120 Coordinator of this site? Confirm its status | Kirkland | United States | Unknown status |
| Northwell Health /ID# 253469 Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Cleveland Clinic Lou Ruvo Cent /ID# 259390 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| University of Miami /ID# 259396 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of Minnesota - Minneapolis /ID# 268121 Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Vanderbilt University Medical Center /ID# 253474 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Ochsner Medical Center - Jefferson Highway /ID# 269764 Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| N1 Research, LLC /ID# 264221 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Parkinson's Research Centers of America - Palo Alto /ID# 264703 Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| University of Utah /ID# 253471 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Univ Texas HSC San Antonio /ID# 259394 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Inland Northwest Research /ID# 253460 Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Banner Sun Health Research Institute /ID# 253461 Coordinator of this site? Confirm its status | Sun City | United States | Unknown status |
| University of South Florida- Neuroscience Institute /ID# 253470 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| The Movement Disorder Clinic of Oklahoma /ID# 253463 Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Georgetown University Hospital /ID# 259381 Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Atrium Health Wake Forest Baptist Medical Center /ID# 259387 Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
Related publications
- Real-World Safety and Effectiveness of 24-Hour Foslevodopa/Foscarbidopa in Parkinson's Disease: ROSSINI Study 6-Month Interim Results.Neurol Ther · 2026 · PMID 42098450
This page is information, not medical advice. Discuss any trial with your doctor.