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Clinical Trials in Germany / NCT06107426
Active, not recruiting Observational

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

NCT06107426 · tracked via the Priya Life Science Germany tracker
Sponsor
Phase
Observational
Started
2024-01-24
Last updated
2026-04-27

Condition(s) studied

Parkinson's Disease (PD)

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
University of Alabama at Birmingham - Main /ID# 253477 Birmingham Alabama
Banner Sun Health Research Institute /ID# 253461 Sun City Arizona
Parkinson's Research Centers of America - Palo Alto /ID# 264703 Palo Alto California
Georgetown University Hospital /ID# 259381 Washington D.C. District of Columbia
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465 Boca Raton Florida
University of Florida College of Medicine /ID# 259383 Gainesville Florida
University of Miami /ID# 259396 Miami Florida
N1 Research, LLC /ID# 264221 Orlando Florida
University of South Florida- Neuroscience Institute /ID# 253470 Tampa Florida
Northwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977 Chicago Illinois
Ochsner Medical Center - Jefferson Highway /ID# 269764 New Orleans Louisiana
Boston Medical Center Health System /ID# 269765 Brighton Massachusetts
University of Minnesota - Minneapolis /ID# 268121 Minneapolis Minnesota
Kansas City VA Medical Center /ID# 253466 Kansas City Missouri
Cleveland Clinic Lou Ruvo Cent /ID# 259390 Las Vegas Nevada
David L. Kreitzman, MD, PC /ID# 259397 Commack New York
Northwell Health /ID# 253469 Lake Success New York
Novant Health Neurology and Sleep /ID# 259391 Charlotte North Carolina
Atrium Health Wake Forest Baptist Medical Center /ID# 259387 Winston-Salem North Carolina
NeuroCare Center /ID# 259392 Canton Ohio
The Movement Disorder Clinic of Oklahoma /ID# 253463 Tulsa Oklahoma
Vanderbilt University Medical Center /ID# 253474 Nashville Tennessee
Texas Movement Disorder Specialists /ID# 253473 Georgetown Texas
Univ Texas HSC San Antonio /ID# 259394 San Antonio Texas
University of Utah /ID# 253471 Salt Lake City Utah
Evergreenhealth Medical Center /ID# 268120 Kirkland Washington
Inland Northwest Research /ID# 253460 Spokane Washington
Westmead Hospital /ID# 259670 Westmead New South Wales
The Royal Melbourne Hospital /ID# 259671 Parkville Victoria
Klinik Ottakring /ID# 262773 Vienna State of Vienna
Medizinische Universitaet Graz /ID# 262774 Graz Styria
Medizinische Universitaet Innsbruck /ID# 262775 Innsbruck Tyrol
Kepler Universitaetsklinikum GmbH /ID# 262776 Linz Upper Austria
University of Calgary /ID# 262833 Calgary Alberta
The Ottawa Hospital - General Campus /ID# 263315 Ottawa Ontario
CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269689 Montreal Quebec
Centre de Recherche St-Louis /ID# 262746 Québec Quebec
Bispebjerg Hospital /ID# 252032 Copenhagen Capital Region
Rigshospitalet Glostrup /ID# 252035 Glostrup Municipality Capital Region
Odense University Hospital /ID# 252036 Odense Region Syddanmark

+ 28 more sites — see the full list on the official registry below.

More AbbVie trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06107426 on ClinicalTrials.gov ↗ ← All trials in Germany