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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
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

Full criteria on ClinicalTrials.gov

Sites (68)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Graz /ID# 262774
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GrazAustriaUnknown status
Medizinische Universitaet Innsbruck /ID# 262775
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InnsbruckAustriaUnknown status
Kepler Universitaetsklinikum GmbH /ID# 262776
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LinzAustriaUnknown status
Klinik Ottakring /ID# 262773
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ViennaAustriaUnknown status
The Royal Melbourne Hospital /ID# 259671
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ParkvilleAustraliaUnknown status
Westmead Hospital /ID# 259670
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WestmeadAustraliaUnknown status
University of Calgary /ID# 262833
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CalgaryCanadaUnknown status
CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269689
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MontrealCanadaUnknown status
The Ottawa Hospital - General Campus /ID# 263315
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OttawaCanadaUnknown status
Centre de Recherche St-Louis /ID# 262746
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QuébecCanadaUnknown status
Kliniken Beelitz GmbH /ID# 252665
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Beelitz-HeilstättenGermanyUnknown status
Knappschaftskrankenhaus Bottrop /ID# 252274
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BottropGermanyUnknown status
Krankenhaus Martha-Maria Halle-Doelau /ID# 260372
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HalleGermanyUnknown status
Klinikum der Universitaet Muenchen Grosshadern /ID# 255574
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MunichGermanyUnknown status
Klinikum Osnabrueck GmbH /ID# 252275
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OsnabrückGermanyUnknown status
Klinikum Ernst von Bergmann /ID# 252375
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PotsdamGermanyUnknown status
Parkinson-Klinik Ortenau GmbH&Co KG /ID# 252376
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WolfachGermanyUnknown status
Bispebjerg Hospital /ID# 252032
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CopenhagenDenmarkUnknown status
Rigshospitalet Glostrup /ID# 252035
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Glostrup MunicipalityDenmarkUnknown status
Odense University Hospital /ID# 252036
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OdenseDenmarkUnknown status
Hospital General Universitario de Elche /ID# 254438
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ElcheSpainUnknown status
Hospital Universitario Virgen de las Nieves /ID# 257588
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GranadaSpainUnknown status
Hospital Clinico San Carlos /ID# 260922
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MadridSpainUnknown status
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260921
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MajadahondaSpainUnknown status
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261402
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Santiago de CompostelaSpainUnknown status
Hospital Universitario Virgen del Rocio /ID# 254437
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SevilleSpainUnknown status
Rambam Health Care Campus- Haifa /ID# 260421
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HaifaIsraelUnknown status
Shaare Zedek Medical Center /ID# 257715
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JerusalemIsraelUnknown status
Hadassah Medical Center-Hebrew University /ID# 257717
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JerusalemIsraelUnknown status
Rabin Medical Center. /ID# 257716
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Petah TikvaIsraelUnknown status
The Chaim Sheba Medical Center /ID# 254823
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Ramat GanIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 254824
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Tel AvivIsraelUnknown status
Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308
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BrasovRomaniaUnknown status
Spitalul Clinic Colentina /ID# 252250
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BucharestRomaniaUnknown status
Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251
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ConstanțaRomaniaUnknown status
Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 252247
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Târgu MureşRomaniaUnknown status
Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248
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TimișoaraRomaniaUnknown status
Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249
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TimișoaraRomaniaUnknown status
Sahlgrenska Universitetssjukhuset /ID# 252115
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GothenburgSwedenUnknown status
Centrum for neurologi /ID# 252118
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StockholmSwedenUnknown status
Uppsala University Hospital /ID# 252119
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UppsalaSwedenUnknown status
University of Alabama at Birmingham - Main /ID# 253477
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BirminghamUnited StatesUnknown status
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465
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Boca RatonUnited StatesUnknown status
Boston Medical Center Health System /ID# 269765
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BrightonUnited StatesUnknown status
NeuroCare Center /ID# 259392
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CantonUnited StatesUnknown status
Novant Health Neurology and Sleep /ID# 259391
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CharlotteUnited StatesUnknown status
Northwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977
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ChicagoUnited StatesUnknown status
David L. Kreitzman, MD, PC /ID# 259397
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CommackUnited StatesUnknown status
University of Florida College of Medicine /ID# 259383
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GainesvilleUnited StatesUnknown status
Texas Movement Disorder Specialists /ID# 253473
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GeorgetownUnited StatesUnknown status
Kansas City VA Medical Center /ID# 253466
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Kansas CityUnited StatesUnknown status
Evergreenhealth Medical Center /ID# 268120
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KirklandUnited StatesUnknown status
Northwell Health /ID# 253469
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Lake SuccessUnited StatesUnknown status
Cleveland Clinic Lou Ruvo Cent /ID# 259390
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Las VegasUnited StatesUnknown status
University of Miami /ID# 259396
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MiamiUnited StatesUnknown status
University of Minnesota - Minneapolis /ID# 268121
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MinneapolisUnited StatesUnknown status
Vanderbilt University Medical Center /ID# 253474
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NashvilleUnited StatesUnknown status
Ochsner Medical Center - Jefferson Highway /ID# 269764
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New OrleansUnited StatesUnknown status
N1 Research, LLC /ID# 264221
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OrlandoUnited StatesUnknown status
Parkinson's Research Centers of America - Palo Alto /ID# 264703
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Palo AltoUnited StatesUnknown status
University of Utah /ID# 253471
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Salt Lake CityUnited StatesUnknown status
Univ Texas HSC San Antonio /ID# 259394
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San AntonioUnited StatesUnknown status
Inland Northwest Research /ID# 253460
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SpokaneUnited StatesUnknown status
Banner Sun Health Research Institute /ID# 253461
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Sun CityUnited StatesUnknown status
University of South Florida- Neuroscience Institute /ID# 253470
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TampaUnited StatesUnknown status
The Movement Disorder Clinic of Oklahoma /ID# 253463
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TulsaUnited StatesUnknown status
Georgetown University Hospital /ID# 259381
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Washington D.C.United StatesUnknown status
Atrium Health Wake Forest Baptist Medical Center /ID# 259387
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Winston-SalemUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.