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

Last updated: March 13, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06107426
P22-487
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligibility for ABBV-951 therapy in accordance with the approved local label in theparticipating 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-LabelExtension Studies M15-737 and M20-098 who completed these studies withoutsignificant protocol deviations and who did not experience an adverse event (AE) that in the investigator's opinion may indicate an unacceptable safetyrisk.

  • Decision to treat with ABBV-951 (or continue the treatment in Cohort B) made by theclinician prior to any decision to approach the participant to participate in thisstudy.

  • Prior to any study-related procedures being performed, the participant, or legalauthorized representative (LAR) has voluntarily signed an Authorization forUse/Disclosure of Data (AUDD)/informed consent form (ICF) according to nationalregulations after the study has been explained and the participant has had theopportunity to have questions answered.

Exclusion

Exclusion Criteria:

  • Any condition included in the contraindications section of the approved localABBV-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 theinvestigator´s judgment the participant is able to handle the therapy andfollow the study procedures with the help of a permanent caregiver.

  • Participation in a concurrent interventional clinical trial from enrollment andthroughout the study.

  • History of significant skin conditions or disorders per investigator´s judgment. Incase of temporary affections like recent sunburn, acne, scar tissue, tattoo, openwound, branding, or colorations, the participant should not be included if theinvestigator considers these as interfering with the infusion of study drug or withstudy assessments.

Study Design

Total Participants: 450
Study Start date:
January 24, 2024
Estimated Completion Date:
May 31, 2029

Connect with a study center

  • Kepler Universitaetsklinikum GmbH /ID# 262776

    Linz, Oberoesterreich 4020
    Austria

    Active - Recruiting

  • Medizinische Universitaet Graz /ID# 262774

    Graz, Steiermark 8010
    Austria

    Active - Recruiting

  • Medizinische Universitaet Innsbruck /ID# 262775

    Innsbruck, Tirol 6020
    Austria

    Active - Recruiting

  • Klinik Ottakring /ID# 262773

    Vienna, Wien 1160
    Austria

    Active - Recruiting

  • University of Calgary /ID# 262833

    Calgary, Alberta T2N 4Z6
    Canada

    Active - Recruiting

  • The Ottawa Hospital - General Campus /ID# 263315

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

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

    Montreal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • Centre de Recherche St-Louis /ID# 262746

    Quebec City, Quebec G1W 4R4
    Canada

    Active - Recruiting

  • Bispebjerg Hospital /ID# 252032

    Copenhagen, Hovedstaden 2400
    Denmark

    Active - Recruiting

  • Rigshospitalet Glostrup /ID# 252035

    Glostrup, Hovedstaden 2600
    Denmark

    Active - Recruiting

  • Odense University Hospital /ID# 252036

    Odense, Syddanmark 5000
    Denmark

    Active - Recruiting

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

    Wolfach, Baden-Wuerttemberg 77709
    Germany

    Active - Recruiting

  • LMU Klinikum Campus Grosshadern /ID# 255574

    Muenchen, Bayern 81377
    Germany

    Active - Recruiting

  • Klinikum Ernst von Bergmann /ID# 252375

    Potsdam, Brandenburg 14467
    Germany

    Active - Recruiting

  • Klinikum Osnabrueck GmbH /ID# 252275

    Osnabrueck, Niedersachsen 49076
    Germany

    Active - Recruiting

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

    Halle (Saale), Sachsen-Anhalt 06120
    Germany

    Active - Recruiting

  • Kliniken Beelitz GmbH /ID# 252665

    Beelitz-Heilstaetten, 14547
    Germany

    Active - Recruiting

  • Knappschaftskrankenhaus Bottrop /ID# 252274

    Bottrop, 46242
    Germany

    Active - Recruiting

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

    Wolfach, 77709
    Germany

    Active - Recruiting

  • Rambam Health Care Campus /ID# 260421

    Haifa, H_efa 3525408
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 254823

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 254824

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center /ID# 257715

    Jerusalem, Yerushalayim 91031
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 257716

    Haifa, 4941492
    Israel

    Active - Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 257717

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 257716

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248

    Timisoara, Timis 300736
    Romania

    Active - Recruiting

  • Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249

    Timisoara, Timis 300736
    Romania

    Active - Recruiting

  • Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308

    Brasov, 500326
    Romania

    Active - Recruiting

  • Spitalul Clinic Colentina /ID# 252250

    Bucuresti, 020121
    Romania

    Active - Recruiting

  • Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251

    Constanta, 900591
    Romania

    Active - Recruiting

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

    Targu Mures, 540136
    Romania

    Active - Recruiting

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

    Santiago de Compostela, A Coruna 15706
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Santiago-CHUS /ID# 261402

    Santiago de Compostela, A Coruna 15706
    Spain

    Active - Recruiting

  • Hospital General Universitario de Elche /ID# 254438

    Elche, Alicante 03203
    Spain

    Active - Recruiting

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

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves /ID# 257588

    Granada, 18014
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos /ID# 260922

    Madrid, 28040
    Spain

    Active - Recruiting

  • Duplicate_Hospital Universitario Virgen del Rocio /ID# 254437

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio /ID# 254437

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Centrum for neurologi /ID# 252118

    Stockholm, Stockholms Lan 113 65
    Sweden

    Active - Recruiting

  • Uppsala University Hospital /ID# 252119

    Uppsala, Uppsala Lan 75185
    Sweden

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset /ID# 252115

    Göteborg, Vastra Gotalands Lan 413 46
    Sweden

    Active - Recruiting

  • Banner Sun Health Research Institute /ID# 253461

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • Parkinson's Disease and Movement Disorders Center /ID# 264703

    Palo Alto, California 94301
    United States

    Active - Recruiting

  • Parkinson's Disease and Movement Disorders Center of Silicon Valley /ID# 264703

    Palo Alto, California 94301
    United States

    Active - Recruiting

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

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • N1 Research, LLC /ID# 264221

    Orlando, Florida 32825-3769
    United States

    Active - Recruiting

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

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Northwestern /ID# 266977

    Chicago, Illinois 60611-3246
    United States

    Active - Recruiting

  • Kansas City VA Medical Center /ID# 253466

    Kansas City, Missouri 64128
    United States

    Active - Recruiting

  • Cleveland Clinic Lou Ruvo Cent /ID# 259390

    Las Vegas, Nevada 89106-0100
    United States

    Active - Recruiting

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

    Commack, New York 11725-6021
    United States

    Active - Recruiting

  • Novant Health Neurology and Sleep /ID# 259391

    Charlotte, North Carolina 28207-1100
    United States

    Active - Recruiting

  • NeuroCare Center /ID# 259392

    Canton, Ohio 44718-2531
    United States

    Active - Recruiting

  • The Movement Disorder Clinic of Oklahoma /ID# 253463

    Tulsa, Oklahoma 74136-6378
    United States

    Active - Recruiting

  • Texas Movement Disorder Specialists /ID# 253473

    Georgetown, Texas 78628-4126
    United States

    Active - Recruiting

  • Univ Texas HSC San Antonio /ID# 259394

    San Antonio, Texas 78229-3901
    United States

    Active - Recruiting

  • Inland Northwest Research /ID# 253460

    Spokane, Washington 99202-1342
    United States

    Active - Recruiting

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