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

NCT06107426 · AbbVie
In plain English

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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)
About this study
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 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 design
Enrollment target: 450 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-01-24
Estimated completion: 2029-05
Last updated: 2025-12-24
Primary outcomes
  • Change From Baseline in OFF Time (hours) (Up to approximately 3 years)
Sponsor
AbbVie · industry
Contacts & investigators
ContactLars Bergmann · contact · lars.bergmann@abbvie.com · +49(0)170 4538568
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (68)
University of Alabama at Birmingham - Main /ID# 253477Recruiting
Birmingham, Alabama, United States
Banner Sun Health Research Institute /ID# 253461Recruiting
Sun City, Arizona, United States
Parkinson's Research Centers of America - Palo Alto /ID# 264703Recruiting
Palo Alto, California, United States
Georgetown University Hospital /ID# 259381Recruiting
Washington D.C., District of Columbia, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465Recruiting
Boca Raton, Florida, United States
University of Florida College of Medicine /ID# 259383Recruiting
Gainesville, Florida, United States
University of Miami /ID# 259396Recruiting
Miami, Florida, United States
N1 Research, LLC /ID# 264221Recruiting
Orlando, Florida, United States
University of South Florida- Neuroscience Institute /ID# 253470Recruiting
Tampa, Florida, United States
Northwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977Recruiting
Chicago, Illinois, United States
Ochsner Medical Center - Jefferson Highway /ID# 269764Recruiting
New Orleans, Louisiana, United States
Boston Medical Center Health System /ID# 269765Recruiting
Brighton, Massachusetts, United States
University of Minnesota - Minneapolis /ID# 268121Recruiting
Minneapolis, Minnesota, United States
Kansas City VA Medical Center /ID# 253466Recruiting
Kansas City, Missouri, United States
Cleveland Clinic Lou Ruvo Cent /ID# 259390Recruiting
Las Vegas, Nevada, United States
David L. Kreitzman, MD, PC /ID# 259397Recruiting
Commack, New York, United States
Northwell Health /ID# 253469Recruiting
Lake Success, New York, United States
Novant Health Neurology and Sleep /ID# 259391Recruiting
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 259387Recruiting
Winston-Salem, North Carolina, United States
NeuroCare Center /ID# 259392Recruiting
Canton, Ohio, United States
The Movement Disorder Clinic of Oklahoma /ID# 253463Recruiting
Tulsa, Oklahoma, United States
Vanderbilt University Medical Center /ID# 253474Recruiting
Nashville, Tennessee, United States
Texas Movement Disorder Specialists /ID# 253473Recruiting
Georgetown, Texas, United States
Univ Texas HSC San Antonio /ID# 259394Recruiting
San Antonio, Texas, United States
University of Utah /ID# 253471Recruiting
Salt Lake City, Utah, United States
Evergreenhealth Medical Center /ID# 268120Recruiting
Kirkland, Washington, United States
Inland Northwest Research /ID# 253460Recruiting
Spokane, Washington, United States
Westmead Hospital /ID# 259670Recruiting
Westmead, New South Wales, Australia
The Royal Melbourne Hospital /ID# 259671Recruiting
Parkville, Victoria, Australia
Klinik Ottakring /ID# 262773Recruiting
Vienna, State of Vienna, Austria
Medizinische Universitaet Graz /ID# 262774Recruiting
Graz, Styria, Austria
Medizinische Universitaet Innsbruck /ID# 262775Recruiting
Innsbruck, Tyrol, Austria
Kepler Universitaetsklinikum GmbH /ID# 262776Recruiting
Linz, Upper Austria, Austria
University of Calgary /ID# 262833Recruiting
Calgary, Alberta, Canada
The Ottawa Hospital - General Campus /ID# 263315Recruiting
Ottawa, Ontario, Canada
CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269689Recruiting
Montreal, Quebec, Canada
Centre de Recherche St-Louis /ID# 262746Recruiting
Québec, Quebec, Canada
Bispebjerg Hospital /ID# 252032Recruiting
Copenhagen, Capital Region, Denmark
Rigshospitalet Glostrup /ID# 252035Active Not Recruiting
Glostrup Municipality, Capital Region, Denmark
Odense University Hospital /ID# 252036Active Not Recruiting
Odense, Region Syddanmark, Denmark
Parkinson-Klinik Ortenau GmbH&Co KG /ID# 252376Recruiting
Wolfach, Baden-Wurttemberg, Germany
Klinikum der Universitaet Muenchen Grosshadern /ID# 255574Recruiting
Munich, Bavaria, Germany
Klinikum Ernst von Bergmann /ID# 252375Recruiting
Potsdam, Brandenburg, Germany
Klinikum Osnabrueck GmbH /ID# 252275Recruiting
Osnabrück, Lower Saxony, Germany
Krankenhaus Martha-Maria Halle-Doelau /ID# 260372Recruiting
Halle, Saxony-Anhalt, Germany
Kliniken Beelitz GmbH /ID# 252665Recruiting
Beelitz-Heilstätten, Germany
Knappschaftskrankenhaus Bottrop /ID# 252274Recruiting
Bottrop, Germany
Shaare Zedek Medical Center /ID# 257715Recruiting
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 254823Recruiting
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 254824Recruiting
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 260421Recruiting
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 257717Recruiting
Jerusalem, Israel
Rabin Medical Center. /ID# 257716Recruiting
Petah Tikva, Israel
Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248Recruiting
Timișoara, Timiș County, Romania
Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249Recruiting
Timișoara, Timiș County, Romania
Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308Recruiting
Brasov, Romania
Spitalul Clinic Colentina /ID# 252250Recruiting
Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251Recruiting
Constanța, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 252247Recruiting
Târgu Mureş, Romania
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261402Completed
Santiago de Compostela, A Coruna, Spain
Hospital General Universitario de Elche /ID# 254438Recruiting
Elche, Alicante, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260921Recruiting
Majadahonda, Madrid, Spain
Hospital Universitario Virgen de las Nieves /ID# 257588Recruiting
Granada, Spain
Hospital Clinico San Carlos /ID# 260922Recruiting
Madrid, Spain
Hospital Universitario Virgen del Rocio /ID# 254437Recruiting
Seville, Spain
Centrum for neurologi /ID# 252118Recruiting
Stockholm, Stockholm County, Sweden
Uppsala University Hospital /ID# 252119Recruiting
Uppsala, Uppsala County, Sweden
Sahlgrenska Universitetssjukhuset /ID# 252115Recruiting
Gothenburg, Västra Götaland County, Sweden
Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease · TrialPath