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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

2026-10-06

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 (192)

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

UCLA Neurology Outpatient Clinic

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

Stanford Neuroscience Health Center (SNHC)

Stanford, 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

Baptist Hospital of Miami

Miami, Florida, United States

Charter Research - Winter Park/Orlando

Orlando, Florida, United States

Advent Health Orlando

Orlando, Florida, United States

USF Parkinsons Disease and Movement Disorders Center

Tampa, Florida, United States

Grady Memorial Hospital

Atlanta, Georgia, 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

Hackensack University Medical Center;Department of Neurology, Neuroscience Institute

Paramus, New Jersey, 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

Columbia University Medical Center

New York, New York, United States

Asheville Neurology

Asheville, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

NeuroCare Center

Canton, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

University Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Avera Medical Group

Sioux Falls, South Dakota, United States

Veracity Neuroscience

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Neurology PA

Dallas, Texas, United States

Central Texas Neurology Consultants

Round Rock, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, 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

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

Royal Melbourne Hospital

Parkville, 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

Santa Casa de Misericordia de Salvador

Salvador, Estado de Bahia, Brazil

L2 Ip Instituto de Pesquisas Clinicas Ltda ME

Brasília, Federal District, Brazil

Hospital das Clinicas - UFMG

Belo Horizonte, Minas Gerais, 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 Ribeirão Preto - Universidade de Sao Paulo

Ribeirão Preto, São Paulo, 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

University Health Network

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

Xuanwu Hospital, Capital Medical University

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

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

The Second Affiliated Hospital of Soochow 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

Regionshospitalet Gødstrup;Neurologisk Afdeling

Herning, Denmark

Bispebjerg Hospital;Neurologisk Afdeling

København NV, Denmark

And 92 more locations on ClinicalTrials.gov