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NCT06107426 · ClinicalTrials.gov registry record
Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease
A clinical trial of Parkinsons Disease (PD), sponsored by AbbVie.
- Recruiting
- Registry status
- 450
- Enrollment target
- 20
- Study locations
NCT06107426: Recruiting study of Parkinsons Disease (PD), sponsored by AbbVie.
NCT06107426 is a study of Parkinsons Disease (PD) that is actively recruiting participants, run by AbbVie. The registered enrollment target is 450 participants, above the 96-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target (369% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06107426, a study of Parkinsons Disease (PD), is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- 450 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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).
Conditions Studied
Study Locations (20)
Florida
- Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465 - Boca Raton
- University of Florida College of Medicine /ID# 259383 - Gainesville
- University of Miami /ID# 259396 - Miami
- N1 Research, LLC /ID# 264221 - Orlando
- University of South Florida- Neuroscience Institute /ID# 253470 - Tampa
New York
- David L. Kreitzman, MD, PC /ID# 259397 - Commack
- Northwell Health /ID# 253469 - Lake Success
North Carolina
- Novant Health Neurology and Sleep /ID# 259391 - Charlotte
- Atrium Health Wake Forest Baptist Medical Center /ID# 259387 - Winston-Salem
Alabama
- University of Alabama at Birmingham - Main /ID# 253477 - Birmingham
Arizona
- Banner Sun Health Research Institute /ID# 253461 - Sun City
California
- Parkinson's Research Centers of America - Palo Alto /ID# 264703 - Palo Alto
District of Columbia
- Georgetown University Hospital /ID# 259381 - Washington D.C.
Illinois
- Northwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977 - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2024-01-24 |
| Est. Completion | 2029-05 |
What NCT06107426 shows while recruiting
NCT06107426 is an observational study that tracks outcomes without assigning an intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 96-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target (369% higher).
The record links to 1 condition, with Parkinsons Disease (PD) appearing as the primary indexed condition, and to 0 interventions.
NCT06107426 names 20 study sites across 14 states, led by Florida, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06107426 about?
NCT06107426 is a clinical study titled "Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease". 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-...
What is the current status of trial NCT06107426?
This trial is currently recruiting. The enrollment target is 450 participants. The study started on 2024-01-24. Estimated completion is 2029-05.
What conditions does trial NCT06107426 study?
This clinical trial studies the following conditions: Parkinsons Disease (PD).
Who is sponsoring clinical trial NCT06107426?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06107426 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinsons Disease (PD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06107426's enrollment target sits among peer trials
450 2nd of 19 the highest of 19 other Parkinsons Disease (PD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinsons Disease (PD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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