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ACTIVE NOT RECRUITING
NCT04777331
PHASE2

A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

586

Start Date

2021-05-05

Completion Date

2026-12-30

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

Prasinezumab

Prasinezumab will be administered as an IV infusion to participants Q4W.

DRUG

Placebo

Prasinezumab placebo will be administered to participants.

Locations (110)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Barrow Neurological Institute

Phoenix, Arizona, United States

Neurology Center of North Orange County

Fullerton, California, United States

UC San Diego

La Jolla, California, United States

Keck School of Medicine of USC

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

CenExel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, United States

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

JEM Research LLC

Atlantis, Florida, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

University of South Florida

Tampa, Florida, United States

Charter Research - Winter Park/Orlando

Winter Park, Florida, United States

Northwestern University Feinberg School Of Medicine

Chicago, Illinois, United States

Southern Illinois University, School of Medicine

Springfield, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Quest Research Institute

Farmington Hills, Michigan, United States

Henry Ford Hospital

West Bloomfield, Michigan, United States

Dent Neurological Institute

Amherst, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

University Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Texas Neurology PA

Dallas, Texas, United States

Baylor College of Medicine Medical Center

Houston, Texas, United States

Central Texas Neurology Consultants

Round Rock, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Sentara Neurology Specialists

Norfolk, Virginia, United States

EvergreenHealth Investigational Drug Services

Kirkland, Washington, United States

Inland Northwest Research

Spokane, Washington, United States

Medizinische Universität Graz

Graz, Austria

Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck

Innsbruck, Austria

Klinik Ottakring

Vienna, Austria

Toronto Memory Program

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Clinique Neuro Outaouais

Gatineau, Quebec, Canada

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada

Groupe Hospitalier Pellegrin

Bordeaux, France

Groupement Hospitalier Est - Hôpital Neurologique

Bron, France

Hopital Gabriel Montpied

Clermont-Ferrand, France

Hôpital Henri Mondor

Créteil, France

Hôpital Michallon - Centre d'Investigation Clinique

Grenoble, France

CHU de Limoges - Hôpital Dupuytren

Limoges, France

hopital de la Timone

Marseille, France

CHU Gui de Chauliac

Montpellier, 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

CHU Strasbourg Hpital Hautepierre

Strasbourg, France

CIC - Hôpital Purpan

Toulouse, France

Università degli studi della Campania Luigi Vanvitelli

Naples, Campania, Italy

Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona

Salerno, Campania, Italy

Ospedale Bellaria

Bologna, Emilia-Romagna, Italy

IRCCS San Raffaele;Clinical Trial Center

Rome, Lazio, Italy

Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Irccs A.O.U.San Martino Ist

Genoa, Liguria, Italy

Azienda Ospedaliera Spedali Civili

Brescia, Lombardy, Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

IRCCS Neuromed

Pozzilli (IS), Molise, Italy

A.O.U. Policlinico "G.Rodolico - San Marco"

Catania, Sicily, Italy

A.O. Universitaria Pisana

Pisa, Tuscany, Italy

AO di Perugia - Ospedale S. Maria della Misericordia

Perugia, Umbria, Italy

Azienda Ospedaliera S. Maria

Terni, Umbria, Italy

Azienda Ospedaliera di Padova

Padova, Veneto, Italy

Centre Hospitalier de Luxembourg

Luxembourg, Luxembourg

NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki

?ód?, Poland

NZOZ Vitamed

Bydgoszcz, Poland

Szpital Sw. Wojciecha

Gda?sk, Poland

Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

Krakow, Poland

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

Lublin, Poland

Nmedis sp. z o.o.

Rzeszów, Poland

Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego

Warsaw, Poland

Centrum Medyczne NeuroProtect

Warsaw, Poland

Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.

Warsaw, Poland

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital General De Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Policlínica Guipuzkoa

Donosti-San Sebastián, Guipuzcoa, Spain

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, LA Coruna, Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);

Móstoles, Madrid, Spain

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Virgen del Puerto

Plasencia, Palencia, Spain

Hospital de Cruces

Barakaldo, Vizcaya, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Hospital Clinic Servicio de Neurologia

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario de Burgos. Servicio de Neurología

Burgos, Spain

Hospital Ruber Juan Bravo

Madrid, Spain

Hospital Universitario de la Princesa

Madrid, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario Clínico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Regional Universitario Carlos Haya

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Virgen del Rocío

Seville, Spain

Hospital Universitario Dr. Peset

Valencia, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Servicio de Neurología Hospital Viamed Montecanal.

Zaragoza, Spain

Ninewells Hospital, Dundee- Scotland

Dundee, United Kingdom

Kings College Hospital

London, United Kingdom

Charing Cross Hospital

London, United Kingdom

Campus for Ageing and Vitality

Newcastle, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

North West Anglia NHS Foundation Trust

Peterborough, United Kingdom

Derriford Hospital

Plymouth, United Kingdom