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ACTIVE NOT RECRUITING
NCT03100149
PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

316

Start Date

2017-06-27

Completion Date

2031-12-01

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

DRUG

RO7046015

RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (\>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (\<) 65 kg.

DRUG

RO7046015

RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm.

DRUG

Placebo

RO7046015 placebo will be administered to all participants in the indicated arm.

Locations (55)

Uab Medicine

Birmingham, Alabama, United States

Barrow Neurology Clinics

Phoenix, Arizona, United States

Neurology Center of North Orange County

Fullerton, California, United States

USC Keck Medical Center of USC

Los Angeles, California, United States

University of California at San Francisco

San Francisco, California, United States

CenExel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, United States

Associated Neurologists of Southern CT PC

Fairfield, Connecticut, United States

Molecular Neurolmaging

New Haven, Connecticut, United States

Aventura Neurologic Associates

Aventura, Florida, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

USF Parkinsons Disease and Movement Disorders Center

Tampa, Florida, United States

Northwestern University

Evanston, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Quest Research Institute

Farmington Hills, Michigan, United States

Corewell Health Neurology and Epilepsy - Beltline

Grand Rapids, Michigan, United States

Henry Ford Health System

West Bloomfield, Michigan, United States

Columbia University

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Oregon Health & Science Uni

Portland, Oregon, United States

UNIVERSITY of PENNSYLVANIA

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College

Houston, Texas, United States

Central Texas Neurology Consultants

Round Rock, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Medizinische Universität Innsbruck

Innsbruck, Austria

Groupe Hospitalier Pellegrin

Bordeaux, France

Hopital Gabriel Montpied

Clermont-Ferrand, France

Hopital Henri Mondor

Créteil, France

Hôpital Michallon - Centre d'Investigation Clinique

Grenoble, France

hopital de la Timone

Marseille, France

CHU de Nice Hopital Pasteur

Nice, France

Hopital Pitie-Salpetriere APHP

Paris, France

CHU Poitiers

Poitiers, France

CHU Rouen Charles Nicolle

Rouen, France

CHU de Nantes - Hopital Laennec

Saint-Herblain, France

CIC - Hôpital Purpan

Toulouse, France

Klinik fur Neurologie

Berlin, Germany

Heinrich-Heine Universitätsklinik Düsseldorf

Düsseldorf, Germany

Paracelsus Elena Klinik Kassel

Kassel, Germany

Klinik und Poliklinik für Neurologie Universitätsklinikum

Leipzig, Germany

Philipps Universität Marburg

Marburg, Germany

DZNE Clinical Trial Unit

München, Germany

Universitaettsklinikum Tübingen

Tübingen, Germany

Universitätsklinikum Ulm

Ulm, Germany

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Policlínica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa, Spain

Fundacion Hospital de Alcorcon

Alcorcón, Madrid, Spain

Clinica Universidad de Navarra

Pamplona/iruña, Navarre, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario de la Princesa

Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Spain