Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease
- Conditions
- Parkinson's Disease (PD)
- Registration Number
- NCT06107426
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
-
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.
-
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline in OFF Time (hours) 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (54)
Parkinson's Disease and Movement Disorders Center /ID# 264703
🇺🇸Palo Alto, California, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465
🇺🇸Boca Raton, Florida, United States
University of South Florida- Neuroscience Institute /ID# 253470
🇺🇸Tampa, Florida, United States
Kansas City VA Medical Center /ID# 253466
🇺🇸Kansas City, Missouri, United States
Cleveland Clinic Lou Ruvo Cent /ID# 259390
🇺🇸Las Vegas, Nevada, United States
Novant Health Neurology and Sleep /ID# 259391
🇺🇸Charlotte, North Carolina, United States
The Movement Disorder Clinic of Oklahoma /ID# 253463
🇺🇸Tulsa, Oklahoma, United States
Univ Texas HSC San Antonio /ID# 259394
🇺🇸San Antonio, Texas, United States
Parkinson-Klinik Ortenau GmbH&Co KG /ID# 252376
🇩🇪Wolfach, Baden-Wuerttemberg, Germany
Hospital Universitario Virgen del Rocio /ID# 254437
🇪🇸Sevilla, Spain
Banner Sun Health Research Institute /ID# 253461
🇺🇸Sun City, Arizona, United States
N1 Research, LLC /ID# 264221
🇺🇸Orlando, Florida, United States
Northwestern /ID# 266977
🇺🇸Chicago, Illinois, United States
David L. Kreitzman, MD, PC /ID# 259397
🇺🇸Commack, New York, United States
NeuroCare Center /ID# 259392
🇺🇸Canton, Ohio, United States
Texas Movement Disorder Specialists /ID# 253473
🇺🇸Georgetown, Texas, United States
Inland Northwest Research /ID# 253460
🇺🇸Spokane, Washington, United States
Kepler Universitaetsklinikum GmbH /ID# 262776
🇦🇹Linz, Oberoesterreich, Austria
Medizinische Universitaet Graz /ID# 262774
🇦🇹Graz, Steiermark, Austria
Medizinische Universitaet Innsbruck /ID# 262775
🇦🇹Innsbruck, Tirol, Austria
Klinik Ottakring /ID# 262773
🇦🇹Vienna, Wien, Austria
University of Calgary /ID# 262833
🇨🇦Calgary, Alberta, Canada
The Ottawa Hospital - General Campus /ID# 263315
🇨🇦Ottawa, Ontario, Canada
CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269689
🇨🇦Montreal, Quebec, Canada
Centre de Recherche St-Louis /ID# 262746
🇨🇦Quebec City, Quebec, Canada
Bispebjerg Hospital /ID# 252032
🇩🇰Copenhagen, Hovedstaden, Denmark
Rigshospitalet Glostrup /ID# 252035
🇩🇰Glostrup, Hovedstaden, Denmark
Odense University Hospital /ID# 252036
🇩🇰Odense, Syddanmark, Denmark
LMU Klinikum Campus Grosshadern /ID# 255574
🇩🇪Muenchen, Bayern, Germany
Klinikum Ernst von Bergmann /ID# 252375
🇩🇪Potsdam, Brandenburg, Germany
Klinikum Osnabrueck GmbH /ID# 252275
🇩🇪Osnabrueck, Niedersachsen, Germany
Krankenhaus Martha-Maria Halle-Doelau /ID# 260372
🇩🇪Halle (Saale), Sachsen-Anhalt, Germany
Kliniken Beelitz GmbH /ID# 252665
🇩🇪Beelitz-Heilstaetten, Germany
Knappschaftskrankenhaus Bottrop /ID# 252274
🇩🇪Bottrop, Germany
Hadassah Medical Center-Hebrew University /ID# 257717
🇮🇱Jerusalem, Israel
Spitalul Clinic Colentina /ID# 252250
🇷🇴Bucuresti, Romania
Rambam Health Care Campus /ID# 260421
🇮🇱Haifa, H_efa, Israel
The Chaim Sheba Medical Center /ID# 254823
🇮🇱Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 254824
🇮🇱Tel Aviv, Tel-Aviv, Israel
Shaare Zedek Medical Center /ID# 257715
🇮🇱Jerusalem, Yerushalayim, Israel
Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308
🇷🇴Brasov, Romania
Rabin Medical Center /ID# 257716
🇮🇱Petah Tikva, Israel
Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248
🇷🇴Timisoara, Timis, Romania
Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249
🇷🇴Timisoara, Timis, Romania
Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251
🇷🇴Constanta, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 252247
🇷🇴Targu Mures, Romania
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261402
🇪🇸Santiago de Compostela, A Coruna, Spain
Hospital General Universitario de Elche /ID# 254438
🇪🇸Elche, Alicante, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260921
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario Virgen de las Nieves /ID# 257588
🇪🇸Granada, Spain
Hospital Clinico San Carlos /ID# 260922
🇪🇸Madrid, Spain
Centrum for neurologi /ID# 252118
🇸🇪Stockholm, Stockholms Lan, Sweden
Uppsala University Hospital /ID# 252119
🇸🇪Uppsala, Uppsala Lan, Sweden
Sahlgrenska Universitetssjukhuset /ID# 252115
🇸🇪Göteborg, Vastra Gotalands Lan, Sweden