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NCT03100149 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) 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
- 316
- Enrollment target
- 20
- Study locations
NCT03100149: Active Phase 2 study of Parkinson's Disease, sponsored by Hoffmann-La Roche.
NCT03100149 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 316 participants, below the 633-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03100149, 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
- 316 participants
- Enrollment target
- 20
- Study locations
Study Summary
This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be offered participation in Part 3 open-label extension (all-participants-on-RO7046015-treatment) for an additional 520 weeks.
Primary Outcome
The MDS-UPDRS is a multimodal scale consisting of four parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contains 6 questions and are assessed by the examiner (Range 0-24). Part IB contains 7 questions on non-motor experiences of daily living which was completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor s
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RO7046015
Study Locations (20)
California
- Neurology Center of North Orange County - Fullerton
- USC Keck Medical Center of USC - Los Angeles
- University of California at San Francisco - San Francisco
Florida
- Aventura Neurologic Associates - Aventura
- Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton
- USF Parkinsons Disease and Movement Disorders Center - Tampa
Michigan
- Quest Research Institute - Farmington Hills
- Corewell Health Neurology and Epilepsy - Beltline - Grand Rapids
- Henry Ford Health System - West Bloomfield
Connecticut
- Associated Neurologists of Southern CT PC - Fairfield
- Molecular Neurolmaging - New Haven
New York
- Columbia University - New York
- University of Rochester Medical Center - Rochester
Alabama
- Uab Medicine - Birmingham
Arizona
- Barrow Neurology Clinics - Phoenix
Colorado
- CenExel Rocky Mountain Clinical Research, LLC - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2017-06-27 |
| Est. Completion | 2031-12-01 |
| Phase | Phase 2 |
What the registry record for NCT03100149 still lists
NCT03100149 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, below the 633-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (50% lower).
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.
NCT03100149 names 20 study sites across 12 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT03100149 about?
NCT03100149 is a clinical study titled "A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease". This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhib...
What is the current status of trial NCT03100149?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 316 participants. The study started on 2017-06-27. Estimated completion is 2031-12-01.
What conditions does trial NCT03100149 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT03100149?
The interventions under investigation include: Placebo (DRUG), RO7046015 (DRUG).
Who is sponsoring clinical trial NCT03100149?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03100149 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 NCT03100149's enrollment target sits among peer trials
316 26th of 158 higher than 133 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.
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