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A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease
Sponsor: Hoffmann-La Roche
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
Conditions
Interventions
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.
RO7046015
RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm.
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