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RECRUITING
NCT07174310
PHASE3

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.

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

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2025-11-24

Completion Date

2031-06-30

Last Updated

2026-05-06

Healthy Volunteers

No

Interventions

DRUG

Prasinezumab

Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.

DRUG

Placebo

Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol

Locations (142)

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

Keck School of Medicine of USC

Los Angeles, California, United States

Parkinson?s Research Centers of America ? Palo Alto

Palo Alto, California, United States

Profound Research LLC at The Neurology Center of Southern California

Pasadena, California, United States

UCSF Weill Institute for Neurosciences

San Francisco, California, United States

Rocky Mountain Movement Disorders

Englewood, Colorado, United States

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Georgetown University

Washington D.C., District of Columbia, United States

JEM Research LLC

Atlantis, Florida, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

K2 - Villages

Lady Lake, Florida, United States

K2 Medical Research-Maitland

Maitland, Florida, United States

Charter Research - Winter Park/Orlando

Orlando, Florida, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Northwestern University Feinberg School Of Medicine

Chicago, 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

Washington Uni School of Medicine

St Louis, Missouri, United States

Cleveland Clinic Lou Ruvo

Las Vegas, Nevada, United States

Renown Health

Reno, Nevada, United States

University of New Mexico

Albuquerque, New Mexico, United States

Dent Neurological Institute

Amherst, New York, United States

Parkinson's Research Centers of America - Long Island

Commack, New York, United States

Weill Cornell Medical College

New York, New York, United States

NeuroCare Center

Canton, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Veracity Neuroscience

Memphis, Tennessee, United States

Texas Neurology PA

Dallas, Texas, United States

Central Texas Neurology Consultants

Round Rock, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

VCU Health North Hospital

Richmond, Virginia, United States

West Virginia University

Morgantown, West Virginia, United States

Southern Neurology

Kogarah, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Monash Health

Clayton, Victoria, Australia

The Alfred Hospital

Prahan, Victoria, Australia

Perron Institute for Neurological and Translational Science

Nedlands, Western Australia, Australia

Medizinische Universität Graz

Graz, Austria

Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck

Innsbruck, Austria

Kepler Universitätsklinikum GmbH - Neuromed Campus

Linz, Austria

Medizinische Universität Wien

Vienna, Austria

Klinik Ottakring

Vienna, Austria

L2 Ip Instituto de Pesquisas Clinicas Ltda ME

Brasília, Federal District, Brazil

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

Núcleo de Pesquisa do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*

São José do Rio Preto, São Paulo, Brazil

Centro de Pesquisas Clinicas

São Paulo, São Paulo, Brazil

Toronto Western Hospital

Toronto, Ontario, Canada

CHUM

Montreal, Quebec, Canada

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada

Beijing Friendship Hospital Affiliated of Capital University of Medical Science

Beijing, China

Beijing Tian Tan Hospital,Capital Medical University

Beijing, China

Beijing Hospital of Ministry of Health

Beijing, China

The First Hospital of Jilin University

Changchun, China

West China Hospital of Sichuan University

Chengdu, China

The First Affiliated Hospital, Chongqing Medical University

Chongqing, China

Fujian Medical University Union Hospital

Fuzhou, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

Nanjing Brain Hospital

Nanjing, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

Huashan Hospital, Fudan University

Shanghai, China

The Second Affiliated Hospital of Suzhou University

Suzhou, China

Tianjin Medical University General Hospital

Tianjin, China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Aarhus Universitetshospital Skejby

Aarhus N, Denmark

Bispebjerg Hospital;Neurologisk Afdeling

København NV, Denmark

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, Rhône, France

APHP - Hopital Henri Mondor

Créteil, France

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, France

Kliniken Beelitz GmbH

Beelitz, Germany

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, Germany

Heinrich-Heine Universitätsklinik Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie

Erlangen, Germany

Paracelsus Elena Klinik Kassel

Kassel, Germany

Klinikum rechts der Isar der TU München

Munich, Germany

Universitatsklinikum Munster

Münster, Germany

Universitaettsklinikum Tübingen

Tübingen, Germany

Universitätsklinikum Würzburg, Neurologische Klinik und Poliklinik

Würzburg, Germany

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

Irccs A.O.U.San Martino Ist

Genoa, Liguria, Italy

Azienda Ospedaliera Spedali Civili

Brescia, Lombardy, Italy

Centro Parkinson e Parkinsonismi

Milan, Lombardy, Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

A.O. Universitaria Pisana

Pisa, Tuscany, Italy

Instituto Nacional de Neurologia y Neurocirugia

Mexico City, Mexico CITY (federal District), Mexico

Hospital General de Mexico

Mexico City, Mexico CITY (federal District), Mexico

Podlaskie Centrum Psychogeriatrii

Bia?ystok, Poland

NZOZ Vitamed

Bydgoszcz, Poland

Szpital Sw. Wojciecha

Gda?sk, Poland

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Katowice, 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

Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

Oświęcim, Poland

Nmedis sp. z o.o.

Rzeszów, Poland

NeuroProtect

Warsaw, Poland

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

Warsaw, Poland

Hospital de Braga

Braga, Portugal

Hospital da Luz Coimbra

Coimbra, Portugal

Hospital Dr. Nélio Mendonça;Serviço de Neurologia

Funchal, Portugal

Hospital Pedro Hispano

Matosinhos Municipality, Portugal

CNS - Campus Neurológico

Torres Vedras, Portugal

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Boramae Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital General De Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Policlinica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Universitari Vall d Hebron

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Ruber Juan Bravo

Madrid, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Univ 12 de Octubre

Madrid, Spain

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, Spain

Changhua Christian Hospital

Changhua County, Taiwan

China Medical University Hospital

North Dist., Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Ninewells Hospital, Dundee- Scotland

Dundee, United Kingdom

Royal Devon and Exeter Hospital (Wonford)

Exeter, United Kingdom

Royal London 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

Plymouth Hospitals NHS Trust - Derriford Hospital

Plymouth,Devon, United Kingdom