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

April 24, 2026 updated by: AbbVie

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

427

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital /ID# 259670
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital /ID# 259671
  • Austria
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1160
        • Klinik Ottakring /ID# 262773
    • Styria
      • Graz, Styria, Austria, 8010
        • Medizinische Universitaet Graz /ID# 262774
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medizinische Universitaet Innsbruck /ID# 262775
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Kepler Universitaetsklinikum GmbH /ID# 262776
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary /ID# 262833
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital - General Campus /ID# 263315
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269689
      • Québec, Quebec, Canada, G1W 4R4
        • Centre de Recherche St-Louis /ID# 262746
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2400
        • Bispebjerg Hospital /ID# 252032
      • Glostrup Municipality, Capital Region, Denmark, 2600
        • Rigshospitalet Glostrup /ID# 252035
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Odense University Hospital /ID# 252036
  • Germany
      • Beelitz-Heilstätten, Germany, 14547
        • Kliniken Beelitz GmbH /ID# 252665
      • Bottrop, Germany, 46242
        • Knappschaftskrankenhaus Bottrop /ID# 252274
    • Baden-Wurttemberg
      • Wolfach, Baden-Wurttemberg, Germany, 77709
        • Parkinson-Klinik Ortenau GmbH&Co KG /ID# 252376
    • Bavaria
      • Munich, Bavaria, Germany, 81337
        • Klinikum der Universitaet Muenchen Grosshadern /ID# 255574
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14467
        • Klinikum Ernst von Bergmann /ID# 252375
    • Lower Saxony
      • Osnabrück, Lower Saxony, Germany, 49076
        • Klinikum Osnabrueck GmbH /ID# 252275
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Krankenhaus Martha-Maria Halle-Doelau /ID# 260372
  • Israel
      • Haifa, Israel, 3525408
        • Rambam Health Care Campus- Haifa /ID# 260421
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 257717
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center. /ID# 257716
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 257715
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 254823
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 254824
  • Romania
      • Brasov, Romania, 500326
        • Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308
      • Bucharest, Romania, 020121
        • Spitalul Clinic Colentina /ID# 252250
      • Constanța, Romania, 900591
        • Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251
      • Târgu Mureş, Romania, 540136
        • Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 252247
    • Timiș County
      • Timișoara, Timiș County, Romania, 300736
        • Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248
      • Timișoara, Timiș County, Romania, 300736
        • Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249
  • Spain
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves /ID# 257588
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos /ID# 260922
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio /ID# 254437
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261402
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche /ID# 254438
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260921
  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 113 65
        • Centrum for neurologi /ID# 252118
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 75185
        • Uppsala University Hospital /ID# 252119
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 46
        • Sahlgrenska Universitetssjukhuset /ID# 252115
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham - Main /ID# 253477
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute /ID# 253461
    • California
      • Palo Alto, California, United States, 94301-2011
        • Parkinson's Research Centers of America - Palo Alto /ID# 264703
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Hospital /ID# 259381
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Medicine /ID# 259383
      • Miami, Florida, United States, 33138
        • University of Miami /ID# 259396
      • Orlando, Florida, United States, 32825-3769
        • N1 Research, LLC /ID# 264221
      • Tampa, Florida, United States, 33613
        • University of South Florida- Neuroscience Institute /ID# 253470
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center - Jefferson Highway /ID# 269764
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Boston Medical Center Health System /ID# 269765
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455-0341
        • University of Minnesota - Minneapolis /ID# 268121
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center /ID# 253466
    • Nevada
      • Las Vegas, Nevada, United States, 89106-0100
        • Cleveland Clinic Lou Ruvo Cent /ID# 259390
    • New York
      • Commack, New York, United States, 11725-6021
        • David L. Kreitzman, MD, PC /ID# 259397
      • Lake Success, New York, United States, 11042
        • Northwell Health /ID# 253469
    • North Carolina
      • Charlotte, North Carolina, United States, 28207-1100
        • Novant Health Neurology and Sleep /ID# 259391
      • Winston-Salem, North Carolina, United States, 27157
        • Atrium Health Wake Forest Baptist Medical Center /ID# 259387
    • Ohio
      • Canton, Ohio, United States, 44718-2531
        • NeuroCare Center /ID# 259392
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136-6378
        • The Movement Disorder Clinic of Oklahoma /ID# 253463
    • Tennessee
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt University Medical Center /ID# 253474
    • Texas
      • Georgetown, Texas, United States, 78628-4126
        • Texas Movement Disorder Specialists /ID# 253473
      • San Antonio, Texas, United States, 78229-3901
        • Univ Texas HSC San Antonio /ID# 259394
    • Utah
      • Salt Lake City, Utah, United States, 84112-5500
        • University of Utah /ID# 253471
    • Washington
      • Kirkland, Washington, United States, 98034
        • Evergreenhealth Medical Center /ID# 268120
      • Spokane, Washington, United States, 99202-1342
        • Inland Northwest Research /ID# 253460

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with Advanced PD, treated with ABBV-951 according to label and local reimbursement regulations, where applicable.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort A: ABBV-951
Participants naïve to ABBV-951 will receive ABBV-951 as prescribed by their physician according to the local label.
Cohort B: ABBV-951
Participants transitioning from the Open-Label Extension studies M15-737 and M20-098 will continue to receive ABBV-951.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in OFF Time (hours)
Time Frame: Up to approximately 3 years
The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM).
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P22-487

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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