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NCT07174310PHASE3Recruiting

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

Hoffmann-La Roche

Start Date

11/24/2025

Completion Date

6/30/2031

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.

Eligibility Criteria

Age Range: 50 years to 85 years

Inclusion Criteria: * Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2 * Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria * Has received monotherapy treatment * An MDS-UPDRS Part IV score of 0 at screening and prior to randomization * Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization * Agreement to adhere to the contraception requirements Exclusion Criteria: * Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required * Medical history indicating a parkinsonian syndrome other than idiopathic PD * Diagnosis of a significant neurologic disease other than PD * Chronic uncontrolled hypertension

Interventions

DRUG

Prasinezumab

DRUG

Placebo

Interested in This Trial?

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Conditions

Parkinson's Disease

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Barrow Neurological Institute

Phoenix, Arizona 85013

United States

Neurology Center of North Orange County

Fullerton, California 92835

United States

UC San Diego

La Jolla, California 92037

United States

Keck School of Medicine of USC

Los Angeles, California 900033

United States

UCLA Neurology Outpatient Clinic

Los Angeles, California 90095

United States

Parkinson?s Research Centers of America ? Palo Alto

Palo Alto, California 94301

United States

Profound Research LLC at The Neurology Center of Southern California

Pasadena, California 91105

United States

UCSF Weill Institute for Neurosciences

San Francisco, California 94158

United States

Rocky Mountain Movement Disorders

Englewood, Colorado 80113

United States

Institute for Neurodegenerative Disorders

New Haven, Connecticut 06510

United States

Georgetown University

Washington D.C., District of Columbia 20007

United States

JEM Research LLC

Atlantis, Florida 33462

United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida 33486

United States

K2 - Villages

Lady Lake, Florida 32159

United States

K2 Medical Research-Maitland

Maitland, Florida 32751

United States

Baptist Hospital of Miami

Miami, Florida 33176

United States

Charter Research - Winter Park/Orlando

Orlando, Florida 32803

United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii 96817

United States

Northwestern University Feinberg School Of Medicine

Chicago, Illinois 60611

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Quest Research Institute

Farmington Hills, Michigan 48334

United States

Washington Uni School of Medicine

St Louis, Missouri 63110

United States

Cleveland Clinic Lou Ruvo

Las Vegas, Nevada 89106

United States

Renown Health

Reno, Nevada 89502

United States

Hackensack University Medical Center;Department of Neurology, Neuroscience Institute

Paramus, New Jersey 07652

United States

University of New Mexico

Albuquerque, New Mexico 87106

United States

Dent Neurological Institute

Amherst, New York 14226

United States

Parkinson's Research Centers of America - Long Island

Commack, New York 11725

United States

Weill Cornell Medical College

New York, New York 10021

United States

Asheville Neurology

Asheville, North Carolina 28806

United States

NeuroCare Center

Canton, Ohio 44718

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma 74136

United States

University Pennsylvania Hospital

Philadelphia, Pennsylvania 19107

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

Avera Medical Group

Sioux Falls, South Dakota 57105

United States

Veracity Neuroscience

Memphis, Tennessee 38157

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37212

United States

Texas Neurology PA

Dallas, Texas 75206

United States

Central Texas Neurology Consultants

Round Rock, Texas 78681

United States

University of Vermont Medical Center

Burlington, Vermont 05401

United States

University of Virginia Health System

Charlottesville, Virginia 22903

United States

VCU Health North Hospital

Richmond, Virginia 23298

United States

West Virginia University

Morgantown, West Virginia 26506

United States

Southern Neurology

Kogarah, New South Wales 2217

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Monash Health

Clayton, Victoria 3168

Australia

Royal Melbourne Hospital

Parkville, Victoria 3050

Australia

The Alfred Hospital

Prahan, Victoria 3181

Australia

Perron Institute for Neurological and Translational Science

Nedlands, Western Australia 6009

Australia

Medizinische Universität Graz

Graz, 8036

Austria

Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck

Innsbruck, 6020

Austria

Kepler Universitätsklinikum GmbH - Neuromed Campus

Linz, 4020

Austria

Medizinische Universität Wien

Vienna, 1090

Austria

Klinik Ottakring

Vienna, 1160

Austria

L2 Ip Instituto de Pesquisas Clinicas Ltda ME

Brasília, Federal District 70200-730

Brazil

Hospital das Clinicas - UFMG

Belo Horizonte, Minas Gerais 31270-901

Brazil

Instituto de Neurologia de Curitiba

Curitiba, Paraná 81210-310

Brazil

Núcleo de Pesquisa do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul 90430-001

Brazil

Faculdade de Medicina de Ribeirão Preto - Universidade de Sao Paulo

Ribeirão Preto, São Paulo 14051-140

Brazil

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

São José do Rio Preto, São Paulo 15090-000

Brazil

Centro de Pesquisas Clinicas

São Paulo, São Paulo 01228-200

Brazil

University Health Network

Toronto, Ontario M5G 2C4

Canada

CHUM

Montreal, Quebec H2X 0A9

Canada

Montreal Neurological Institute and Hospital

Montreal, Quebec H3A 2B4

Canada

Beijing Friendship Hospital Affiliated of Capital University of Medical Science

Beijing, 100050

China

Xuanwu Hospital, Capital Medical University

Beijing, 100053

China

Beijing Tian Tan Hospital,Capital Medical University

Beijing, 100071

China

Beijing Hospital of Ministry of Health

Beijing, 100730

China

The First Hospital of Jilin University

Changchun, 130021

China

West China Hospital of Sichuan University

Chengdu, 610041

China

The First Affiliated Hospital, Chongqing Medical University

Chongqing, 400016

China

Fujian Medical University Union Hospital

Fuzhou, 350001

China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510080

China

Guangdong Provincial People's Hospital

Guangzhou, 510115

China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120

China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, 310009

China

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

Hangzhou,

China

Nanjing Brain Hospital

Nanjing, 210029

China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, 200025

China

Huashan Hospital, Fudan University

Shanghai, 200040

China

The Second Affiliated Hospital of Soochow University

Suzhou, 215004

China

Tianjin Medical University General Hospital

Tianjin, 300052

China

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

Xi'an, 710061

China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou,

China

Aarhus Universitetshospital Skejby

Aarhus N, 8200

Denmark

Bispebjerg Hospital;Neurologisk Afdeling

København NV, 2400

Denmark

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, Rhône 69003

France

CHU de Clermont-Ferrand - Site Gabriel-Montpied

Clermont-Ferrand, 63000

France

APHP - Hopital Henri Mondor

Créteil, 94010

France

CHU de Grenoble - Hôpital André Michallon

La Tronche, 38700

France

CHU de Limoges - Hôpital Dupuytren

Limoges, 87042

France

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, 34295

France

CHU de Nice Hopital Pasteur

Nice, 06002

France

APHP - Hopital de la Pitie Salpetriere

Paris, 75013

France

Kliniken Beelitz GmbH

Beelitz, 14547

Germany

Charite Universitätsmed. Berlin

Berlin, 10117

Germany

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, 12203

Germany

St. Josef-Hospital, Klinik für Neurologie

Bochum, 44791

Germany

Universitätsklinikum "Carl Gustav Carus"

Dresden, 01307

Germany

Heinrich-Heine Universitätsklinik Düsseldorf

Düsseldorf, 40225

Germany

Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie

Erlangen, 91054

Germany

Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

Freiburg im Breisgau, 79106

Germany

Medizinische Hochschule Hannover, Klinik für Neurologie

Hanover, 30625

Germany

Universitätsklinikum Heidelberg, Neurologische Klinik, Abteilung für Neuroradiologie

Heidelberg, 69120

Germany

Universität Des Saarlandes

Homburg, 66421

Germany

Paracelsus Elena Klinik Kassel

Kassel, 34128

Germany

Klinikum rechts der Isar der TU München

Munich, 81675

Germany

Universitatsklinikum Munster

Münster, 48149

Germany

Universitaettsklinikum Tübingen

Tübingen, 72076

Germany

Universitätsklinikum Würzburg, Neurologische Klinik und Poliklinik

Würzburg, 97080

Germany

Università degli studi della Campania Luigi Vanvitelli

Naples, Campania 80138

Italy

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

Salerno, Campania 84131

Italy

Ospedale Bellaria

Bologna, Emilia-Romagna 40139

Italy

San Raffaele Cassino

Cassino, Lazio 03043

Italy

IRCCS San Raffaele;Clinical Trial Center

Rome, Lazio 00166

Italy

Policlinico Universitario Agostino Gemelli

Rome, Lazio 00168

Italy

Irccs A.O.U.San Martino Ist

Genoa, Liguria 16132

Italy

Azienda Ospedaliera Spedali Civili

Brescia, Lombardy 25100

Italy

Centro Parkinson e Parkinsonismi

Milan, Lombardy 20126

Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy 20132

Italy

IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy 20133

Italy

A.O. Universitaria Pisana

Pisa, Tuscany 56126

Italy

Instituto Nacional de Neurologia y Neurocirugia

Mexico City, Mexico CITY (federal District) 14390

Mexico

Hospital General de Mexico

Mexico City, Mexico CITY (federal District) 6726

Mexico

Podlaskie Centrum Psychogeriatrii

Bia?ystok, 15-756

Poland

NZOZ Vitamed

Bydgoszcz, 85-079

Poland

Szpital Sw. Wojciecha

Gda?sk, 80-462

Poland

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

Katowice, 40-749

Poland

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

Krakow, 31-505

Poland

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

Lublin, 20-410

Poland

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

Oświęcim, 32-600

Poland

Nmedis sp. z o.o.

Rzeszów, 35-232

Poland

NeuroProtect

Warsaw, 01-684

Poland

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

Warsaw, 03-242

Poland

Hospital de Braga

Braga, 4710-243

Portugal

Hospital da Luz Coimbra

Coimbra, 3020-479

Portugal

Hospital Dr. Nélio Mendonça;Serviço de Neurologia

Funchal, 9004-514

Portugal

Hospital da Senhora da Oliveira-Guimarães

Guimarães,

Portugal

Hospital de Santa Maria

Lisbon, 1649-035

Portugal

Hospital Pedro Hispano

Matosinhos Municipality, 4464-513

Portugal

CNS - Campus Neurológico

Torres Vedras, 2560-280

Portugal

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Boramae Medical Center

Seoul, 07061

South Korea

Seoul National University Hospital

Seoul, 110-744

South Korea

Hospital General Universitario de Elche

Elche, Alicante 03203

Spain

Hospital General De Catalunya

Sant Cugat del Vallès, Barcelona 08195

Spain

Policlinica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa 20009

Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, LA Coruna 15006

Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid 28922

Spain

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid 28223

Spain

Hospital Universitari Vall d Hebron

Barcelona, 08035

Spain

Hospital Clinic Barcelona

Barcelona, 08036

Spain

Hospital Ruber Juan Bravo

Madrid, 28006

Spain

Hospital Universitario de La Princesa

Madrid, 28006

Spain

Hospital Univ 12 de Octubre

Madrid, 28041

Spain

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, 29009

Spain

Hospital Universitario Virgen del Rocio

Seville, 41013

Spain

Changhua Christian Hospital

Changhua County, 500

Taiwan

China Medical University Hospital

North Dist., 40447

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Ninewells Hospital, Dundee- Scotland

Dundee, DD2 1SY

United Kingdom

Royal Devon and Exeter Hospital (Wonford)

Exeter, EX2 5DW

United Kingdom

Royal London Hospital

London, E1 1FR

United Kingdom

Charing Cross Hospital

London, W6 8RF

United Kingdom

Campus for Ageing and Vitality

Newcastle, NE4 5PL

United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE

United Kingdom

Plymouth Hospitals NHS Trust - Derriford Hospital

Plymouth,Devon, PL6 8DH

United Kingdom