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NCT04750226 · ClinicalTrials.gov registry record · Phase 3
Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease
A Phase 3 study of Parkinsons Disease (PD), sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
- 20
- Study locations
NCT04750226: Active Phase 3 study of Parkinsons Disease (PD), sponsored by AbbVie.
NCT04750226 is a Phase 3 study of Parkinsons Disease (PD) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 118 participants, roughly in line with the 113-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target. The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04750226, a Phase 3 study of Parkinsons Disease (PD), is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 118 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. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia. Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject a
Conditions Studied
Interventions
- DRUG ABBV-951
Study Locations (20)
California
- Neuro Pain Medical Center /ID# 217720 - Fresno
- Loma Linda University Medical /ID# 217724 - Loma Linda
- University of California, Los Angeles /ID# 218460 - Los Angeles
- SC3 Research Group - Pasadena /ID# 223018 - Pasadena
- University of California, San /ID# 218595 - San Diego
- Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 218607 - West Hollywood
Colorado
- University of Colorado Hospital /ID# 218486 - Aurora
- Alpine Clinical Research Center /ID# 218461 - Boulder
- Denver Neurological Research, LLC /ID# 217811 - Denver
- CenExel Rocky Mountain Clinical Research, LLC /ID# 217731 - Englewood
Florida
- Visionary Investigators Network - Miami /ID# 217726 - Miami
- Renstar Medical Research /ID# 217837 - Ocala
- Neurology Associates Ormond Beach /ID# 217800 - Ormond Beach
- Parkinson's Disease Treatment Center of Southwest Florida /ID# 222679 - Port Charlotte
Arizona
- Xenoscience, Inc /ID# 222515 - Phoenix
- Muhammad Ali Parkinson Center /ID# 218609 - Phoenix
- Movement Disorders Center of Arizona /ID# 218471 - Scottsdale
Alabama
- University of Alabama at Birmingham - Main /ID# 217814 - Birmingham
- University of South Alabama /ID# 218467 - Mobile
District of Columbia
- Georgetown University Hospital /ID# 218599 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2021-02-18 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
What the registry record for NCT04750226 still lists
NCT04750226 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 113-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target.
The record links to 1 condition, with Parkinsons Disease (PD) appearing as the primary indexed condition, and to 1 intervention - of which ABBV-951 is the first listed.
NCT04750226 names 20 study sites across 6 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT04750226 about?
NCT04750226 is a clinical study titled "Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced 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. This study will assess how safe and effective ABBV-951 is in...
What is the current status of trial NCT04750226?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2021-02-18. Estimated completion is 2026-04.
What conditions does trial NCT04750226 study?
This clinical trial studies the following conditions: Parkinsons Disease (PD).
What interventions are being tested in trial NCT04750226?
The interventions under investigation include: ABBV-951 (DRUG).
Who is sponsoring clinical trial NCT04750226?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04750226 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. 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 NCT04750226's enrollment target sits among peer trials
118 6th of 19 higher than 14 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
RECRUITING · Phase 3
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Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
ACTIVE NOT RECRUITING · Phase 3
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Open-Label Safety Study of ADS-5102 in PD Patients With LID
COMPLETED · Phase 3
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Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
COMPLETED · Phase 3
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Transcranial Direct Current Stimulation for Motor Function and Fatigue in PD
RECRUITING · NA
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A Study of NE3107 in Early Parkinson's
RECRUITING · Phase 2
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