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Active, not recruiting Phase 2 Interventional Results available

A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease

ClinicalTrials.gov ID: NCT03100149

Public ClinicalTrials.gov record NCT03100149. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 3:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 11-Year All-Participants-on-Treatment Extension

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03100149
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
316 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 27, 2017 (Actual)
Primary completion
Nov 27, 2019 (Actual)
Completion
Dec 1, 2031 (Estimated)
Last update posted
Sep 11, 2026

2017 – 2031

United States locations

U.S. sites
26
U.S. states
17
U.S. cities
26
Facility City State ZIP Site status
Uab Medicine Birmingham Alabama 35233 —
Barrow Neurology Clinics Phoenix Arizona 85013 —
Neurology Center of North Orange County Fullerton California 92835 —
USC Keck Medical Center of USC Los Angeles California 90033 —
University of California at San Francisco San Francisco California 94115 —
CenExel Rocky Mountain Clinical Research, LLC Englewood Colorado 80113 —
Associated Neurologists of Southern CT PC Fairfield Connecticut 06824 —
Molecular Neurolmaging New Haven Connecticut 06510 —
Aventura Neurologic Associates Aventura Florida 33180 —
Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton Florida 33486 —
USF Parkinsons Disease and Movement Disorders Center Tampa Florida 33613 —
Northwestern University Evanston Illinois 60208 —
University of Kansas Medical Center Kansas City Kansas 66160 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Quest Research Institute Farmington Hills Michigan 48334 —
Corewell Health Neurology and Epilepsy - Beltline Grand Rapids Michigan 49525 —
Henry Ford Health System West Bloomfield Michigan 48322 —
Columbia University New York New York 10032 —
University of Rochester Medical Center Rochester New York 14618 —
The Movement Disorder Clinic of Oklahoma Tulsa Oklahoma 74136 —
Oregon Health & Science Uni Portland Oregon 97239 —
UNIVERSITY of PENNSYLVANIA Philadelphia Pennsylvania 19107 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Baylor College Houston Texas 77030 —
Central Texas Neurology Consultants Round Rock Texas 78681 —
University of Vermont Medical Center Burlington Vermont 05401 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03100149, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 11, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03100149 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →