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Parkinson's Disease (PD)ROSSININCT06107426

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

An observational study of Parkinson's Disease (PD), run by AbbVie at 68 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson's Disease (PD)
How many people
427 participants
Where
68 sitesin 10 countries
Study dates
24 Jan 2024to May 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

68 sites in 10 countries.

68 sites in 10 countries

United States27 sites

  • University of Alabama at Birmingham - Main /ID# 253477

    Birmingham, Alabama, 35233

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

    Boca Raton, Florida, 33486

  • Boston Medical Center Health System /ID# 269765

    Brighton, Massachusetts, 02135

  • NeuroCare Center /ID# 259392

    Canton, Ohio, 44718-2531

  • Novant Health Neurology and Sleep /ID# 259391

    Charlotte, North Carolina, 28207-1100

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

    Chicago, Illinois, 60611

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

    Commack, New York, 11725-6021

  • University of Florida College of Medicine /ID# 259383

    Gainesville, Florida, 32610

  • Texas Movement Disorder Specialists /ID# 253473

    Georgetown, Texas, 78628-4126

  • Kansas City VA Medical Center /ID# 253466

    Kansas City, Missouri, 64128

  • Evergreenhealth Medical Center /ID# 268120

    Kirkland, Washington, 98034

  • Northwell Health /ID# 253469

    Lake Success, New York, 11042

  • Cleveland Clinic Lou Ruvo Cent /ID# 259390

    Las Vegas, Nevada, 89106-0100

  • University of Miami /ID# 259396

    Miami, Florida, 33138

  • University of Minnesota - Minneapolis /ID# 268121

    Minneapolis, Minnesota, 55455-0341

  • Vanderbilt University Medical Center /ID# 253474

    Nashville, Tennessee, 37232-0011

  • Ochsner Medical Center - Jefferson Highway /ID# 269764

    New Orleans, Louisiana, 70121

  • N1 Research, LLC /ID# 264221

    Orlando, Florida, 32825-3769

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

    Palo Alto, California, 94301-2011

  • University of Utah /ID# 253471

    Salt Lake City, Utah, 84112-5500

  • Univ Texas HSC San Antonio /ID# 259394

    San Antonio, Texas, 78229-3901

  • Inland Northwest Research /ID# 253460

    Spokane, Washington, 99202-1342

  • Banner Sun Health Research Institute /ID# 253461

    Sun City, Arizona, 85351

  • University of South Florida- Neuroscience Institute /ID# 253470

    Tampa, Florida, 33613

  • The Movement Disorder Clinic of Oklahoma /ID# 253463

    Tulsa, Oklahoma, 74136-6378

  • Georgetown University Hospital /ID# 259381

    Washington D.C., District of Columbia, 20007

  • Atrium Health Wake Forest Baptist Medical Center /ID# 259387

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany7 sites

  • Kliniken Beelitz GmbH /ID# 252665

    Beelitz-Heilstätten, 14547

  • Knappschaftskrankenhaus Bottrop /ID# 252274

    Bottrop, 46242

  • Krankenhaus Martha-Maria Halle-Doelau /ID# 260372

    Halle, Saxony-Anhalt, 06120

  • Klinikum der Universitaet Muenchen Grosshadern /ID# 255574

    Munich, Bavaria, 81337

  • Klinikum Osnabrueck GmbH /ID# 252275

    Osnabrück, Lower Saxony, 49076

  • Klinikum Ernst von Bergmann /ID# 252375

    Potsdam, Brandenburg, 14467

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

    Wolfach, Baden-Wurttemberg, 77709

Other trials in Germany

Israel6 sites

  • Rambam Health Care Campus- Haifa /ID# 260421

    Haifa, 3525408

  • Shaare Zedek Medical Center /ID# 257715

    Jerusalem, Jerusalem, 91031

  • Hadassah Medical Center-Hebrew University /ID# 257717

    Jerusalem, 91120

  • Rabin Medical Center. /ID# 257716

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 254823

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 254824

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Romania6 sites

  • Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308

    Brasov, 500326

  • Spitalul Clinic Colentina /ID# 252250

    Bucharest, 020121

  • Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251

    Constanța, 900591

  • Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 252247

    Târgu Mureş, 540136

  • Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248

    Timișoara, Timiș County, 300736

  • Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249

    Timișoara, Timiș County, 300736

Other trials in Romania

Spain6 sites

  • Hospital General Universitario de Elche /ID# 254438

    Elche, Alicante, 03203

  • Hospital Universitario Virgen de las Nieves /ID# 257588

    Granada, 18014

  • Hospital Clinico San Carlos /ID# 260922

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260921

    Majadahonda, Madrid, 28222

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

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen del Rocio /ID# 254437

    Seville, 41013

Other trials in Spain

Austria4 sites

  • Medizinische Universitaet Graz /ID# 262774

    Graz, Styria, 8010

  • Medizinische Universitaet Innsbruck /ID# 262775

    Innsbruck, Tyrol, 6020

  • Kepler Universitaetsklinikum GmbH /ID# 262776

    Linz, Upper Austria, 4020

  • Klinik Ottakring /ID# 262773

    Vienna, State of Vienna, 1160

Other trials in Austria

Canada4 sites

  • University of Calgary /ID# 262833

    Calgary, Alberta, T2N 4Z6

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

    Montreal, Quebec, H2X 0A9

  • The Ottawa Hospital - General Campus /ID# 263315

    Ottawa, Ontario, K1H 8L6

  • Centre de Recherche St-Louis /ID# 262746

    Québec, Quebec, G1W 4R4

Other trials in Canada

Denmark3 sites

  • Bispebjerg Hospital /ID# 252032

    Copenhagen, Capital Region, 2400

  • Rigshospitalet Glostrup /ID# 252035

    Glostrup Municipality, Capital Region, 2600

  • Odense University Hospital /ID# 252036

    Odense, Region Syddanmark, 5000

Other trials in Denmark

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset /ID# 252115

    Gothenburg, Västra Götaland County, 413 46

  • Centrum for neurologi /ID# 252118

    Stockholm, Stockholm County, 113 65

  • Uppsala University Hospital /ID# 252119

    Uppsala, Uppsala County, 75185

Other trials in Sweden

Australia2 sites

  • The Royal Melbourne Hospital /ID# 259671

    Parkville, Victoria, 3050

  • Westmead Hospital /ID# 259670

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official 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)

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.

Read more

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.

Keywords
Parkinson's Disease, Advance Parkinson's Disease, ABBV-951, Foslevodopa/foscarbidopa
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06107426
Study groupRoleWhat they receive
Cohort A: ABBV-951Participants naïve to ABBV-951 will receive ABBV-951 as prescribed by their physician according to the local label.
Cohort B: ABBV-951Participants transitioning from the Open-Label Extension studies M15-737 and M20-098 will continue to receive ABBV-951.
Country Specific Sub-StudyParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in OFF Time (hours)

    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).

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start24 Jan 2024
  3. Primary completionMay 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
427 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06107426
Sponsor's protocol ID
P22-487
Acronym
ROSSINI
Status last verified
Apr 2026
First submitted
25 Oct 2023
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jost WH, Bergquist F, Evans A, Hassin-Baer S, Hauser RA, Henriksen T, Malaty IA, Mestre TA, Mir P, Rodriguez R, Schwingenschuh P, Simu M, Bergmann L, Zhou TT, Caughlin S, Gopalkrishnan M, Kukreja P, O'Meara M, Parra JC, Shah MB, Aldred J. Real-World Safety and Effectiveness of 24-Hour Foslevodopa/Foscarbidopa in Parkinson's Disease: ROSSINI Study 6-Month Interim Results. Neurol Ther. 2026 Aug;15(4):1743-1762. doi: 10.1007/s40120-026-00948-6. Epub 2026 May 7.

    PubMed 42098450

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease (PD), run by AbbVie at 68 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Germany, Israel, Romania, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in OFF Time (hours) (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06107426, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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