Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04777331 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
A Phase 2 study of Parkinson's Disease, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 2
- Development phase
- 586
- Enrollment target
- 20
- Study locations
NCT04777331: Active Phase 2 study of Parkinson's Disease, sponsored by Hoffmann-La Roche.
NCT04777331 is a Phase 2 study of Parkinson's Disease that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 586 participants, roughly in line with the 632-participant average among 158 other Parkinson's Disease trials with a reported enrollment target. The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04777331, a Phase 2 study of Parkinson's Disease, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 586 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.
Primary Outcome
Time to confirmed motor progression event was the first time point of a worsening event defined as either \>= 5 points increase in MDS-UPDRS Part III score (assessed in "OFF" medication state) from baseline sustained over 2 consecutive assessments or a change in medication after first occurrence of \>= 5 points increase in MDS-UPDRS Part III score from baseline \& before follow-up assessment. MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Prasinezumab
Study Locations (20)
California
- Neurology Center of North Orange County - Fullerton
- UC San Diego - La Jolla
- Keck School of Medicine of USC - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- University of California San Francisco - San Francisco
Florida
- JEM Research LLC - Atlantis
- Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton
- Renstar Medical Research - Ocala
- University of South Florida - Tampa
- Charter Research - Winter Park/Orlando - Winter Park
Illinois
- Northwestern University Feinberg School Of Medicine - Chicago
- Southern Illinois University, School of Medicine - Springfield
Michigan
- Quest Research Institute - Farmington Hills
- Henry Ford Hospital - West Bloomfield
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Barrow Neurological Institute - Phoenix
Colorado
- CenExel Rocky Mountain Clinical Research, LLC - Englewood
Connecticut
- Institute for Neurodegenerative Disorders - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 586 participants |
| Start Date | 2021-05-05 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 2 |
What the registry record for NCT04777331 still lists
NCT04777331 is an interventional study that assigns participants to a tested intervention. The registered 586 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 632-participant average among 158 other Parkinson's Disease trials with a reported enrollment target.
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04777331 names 20 study sites across 10 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT04777331 about?
NCT04777331 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease". This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.
What is the current status of trial NCT04777331?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 586 participants. The study started on 2021-05-05. Estimated completion is 2026-12-30.
What conditions does trial NCT04777331 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT04777331?
The interventions under investigation include: Placebo (DRUG), Prasinezumab (DRUG).
Who is sponsoring clinical trial NCT04777331?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04777331 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson's Disease
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 NCT04777331's enrollment target sits among peer trials
586 15th of 158 higher than 144 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease 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
-
Ketamine for Veterans With Parkinson's Disease
RECRUITING · Phase 2
-
Imaging Depression in Parkinson's Disease
RECRUITING · Phase 2
-
Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease
RECRUITING · Phase 2
-
Tenapanor in Synucleinopathy-Related Constipation
RECRUITING · Phase 2
-
A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04134260 · 586 participants · Phase 3
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial
- NCT06100770 · 586 participants
Aveir AR Coverage With Evidence Development (CED) Study
- NCT06183281 · 586 participants · NA
Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity
- NCT06976203 · 586 participants · Phase 3
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI