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

Last updated: April 3, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Parkinson's Disease

Dyskinesias

Treatment

Prasinezumab

Placebo

Clinical Study ID

NCT07174310
BN44715
2025-522683-32-00
  • Ages 50-85
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Body weight within 40-110 kilograms (kg) (88-242 pounds [lbs]) and a body mass indexwithin 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 torandomization

  • Agreement to adhere to the contraception requirements

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding, or intention of becoming pregnant during the study orwithin 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

Study Design

Total Participants: 900
Treatment Group(s): 2
Primary Treatment: Prasinezumab
Phase: 3
Study Start date:
November 24, 2025
Estimated Completion Date:
June 30, 2031

Connect with a study center

  • Southern Neurology

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Prahan, Victoria 3181
    Australia

    Active - Recruiting

  • Perron Institute for Neurological and Translational Science

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Medizinische Universität Graz

    Graz, 8036
    Austria

    Active - Recruiting

  • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Kepler Universitätsklinikum GmbH - Neuromed Campus

    Linz, 4020
    Austria

    Active - Recruiting

  • Klinik Ottakring

    Vienna, 1160
    Austria

    Active - Recruiting

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná 81210-310
    Brazil

    Active - Recruiting

  • Núcleo de Pesquisa do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul 90430-001
    Brazil

    Active - Recruiting

  • Centro de Pesquisas Clinicas

    São Paulo, São Paulo 01228-200
    Brazil

    Active - Recruiting

  • CHUM

    Montreal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec H3A 2B4
    Canada

    Active - Recruiting

  • CHUM

    Montreal 6077243, Quebec 6115047 H2X 0A9
    Canada

    Active - Recruiting

  • Montreal Neurological Institute and Hospital

    Montreal 6077243, Quebec 6115047 H3A 2B4
    Canada

    Site Not Available

  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science

    Beijing, 100050
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, 130021
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, 610041
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu 1815286, 610041
    China

    Site Not Available

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016
    China

    Active - Recruiting

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing 1814906, 400016
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, 350001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310009
    China

    Active - Recruiting

  • Nanjing Brain Hospital

    Nanjing, 210029
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Suzhou University

    Suzhou, 215025
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Suzhou University

    Suzhou 1886760, 215025
    China

    Site Not Available

  • Aarhus Universitetshospital Skejby

    Aarhus N, 8200
    Denmark

    Active - Recruiting

  • Bispebjerg Hospital;Neurologisk Afdeling

    København NV, 2400
    Denmark

    Active - Recruiting

  • Heinrich-Heine Universitätsklinik Düsseldorf

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Paracelsus Elena Klinik Kassel

    Kassel, 34128
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TU München

    Munich, 81675
    Germany

    Active - Recruiting

  • Università degli studi della Campania Luigi Vanvitelli

    Naples, Campania 80138
    Italy

    Active - Recruiting

  • Università degli studi della Campania Luigi Vanvitelli

    Napoli, Campania 80138
    Italy

    Site Not Available

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

    Salerno, Campania 84131
    Italy

    Active - Recruiting

  • Irccs A.O.U.San Martino Ist

    Genoa, Liguria 16132
    Italy

    Active - Recruiting

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy 20133
    Italy

    Active - Recruiting

  • Hospital General de Mexico

    Mexico City, Mexico CITY (federal District) 6726
    Mexico

    Active - Recruiting

  • Podlaskie Centrum Psychogeriatrii

    Bia?ystok, 15-756
    Poland

    Active - Recruiting

  • NZOZ Vitamed

    Bydgoszcz, 85-079
    Poland

    Active - Recruiting

  • NZOZ Vitamed

    Bydgoszcz 3102014, 85-079
    Poland

    Site Not Available

  • Szpital Sw. Wojciecha

    Gda?sk, 80-462
    Poland

    Active - Recruiting

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

    Katowice, 40-749
    Poland

    Active - Recruiting

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

    Krakow, 31-505
    Poland

    Active - Recruiting

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

    Lublin, 20-410
    Poland

    Active - Recruiting

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

    Oświęcim, 32-600
    Poland

    Active - Recruiting

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

    Oświęcim 3089658, 32-600
    Poland

    Site Not Available

  • Nmedis sp. z o.o.

    Rzeszów, 35-232
    Poland

    Active - Recruiting

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

    Warsaw, 03-242
    Poland

    Active - Recruiting

  • NeuroProtect

    Warsaw, 01-684
    Poland

    Active - Recruiting

  • NeuroProtect

    Warsaw 756135, 01-684
    Poland

    Site Not Available

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Hospital da Luz Coimbra

    Coimbra, 3020-479
    Portugal

    Active - Recruiting

  • Hospital Dr. Nélio Mendonça;Serviço de Neurologia

    Funchal, 9004-514
    Portugal

    Active - Recruiting

  • Hospital Pedro Hispano

    Matosinhos Municipality, 4464-513
    Portugal

    Active - Recruiting

  • CNS - Campus Neurológico

    Torres Vedras, 2560-280
    Portugal

    Active - Recruiting

  • CNS - Campus Neurológico

    Torres Vedras 2262581, 2560-280
    Portugal

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul, 110-744
    South Korea

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    South Korea

    Active - Recruiting

  • Hospital General De Catalunya

    Sant Cugat del Vallès, Barcelona 08195
    Spain

    Active - Recruiting

  • Policlinica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa 20009
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid 28922
    Spain

    Active - Recruiting

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid 28223
    Spain

    Active - Recruiting

  • Hospital Clinic Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Ruber Juan Bravo

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Univ 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Changhua Christian Hospital

    Changhua County, 500
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    North Dist., 40447
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Ninewells Hospital, Dundee- Scotland

    Dundee, DD2 1SY
    United Kingdom

    Active - Recruiting

  • Ninewells Hospital, Dundee- Scotland

    Dundee 2650752, DD2 1SY
    United Kingdom

    Site Not Available

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW
    United Kingdom

    Active - Recruiting

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter 2649808, EX2 5DW
    United Kingdom

    Site Not Available

  • Charing Cross Hospital

    London, W6 8RF
    United Kingdom

    Active - Recruiting

  • Royal London Hospital

    London, E1 1FR
    United Kingdom

    Active - Recruiting

  • Charing Cross Hospital

    London 2643743, W6 8RF
    United Kingdom

    Site Not Available

  • Royal London Hospital

    London 2643743, E1 1FR
    United Kingdom

    Active - Recruiting

  • Campus for Ageing and Vitality

    Newcastle, NE4 5PL
    United Kingdom

    Active - Recruiting

  • Campus for Ageing and Vitality

    Newcastle 6695976, NE4 5PL
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford 2640729, OX3 7LE
    United Kingdom

    Site Not Available

  • Plymouth Hospitals NHS Trust - Derriford Hospital

    Plymouth,Devon, PL6 8DH
    United Kingdom

    Active - Recruiting

  • Plymouth Hospitals NHS Trust - Derriford Hospital

    Plymouth,Devon 2640194, PL6 8DH
    United Kingdom

    Site Not Available

  • Neurology Center of North Orange County

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Keck School of Medicine of USC

    Los Angeles, California 900033
    United States

    Active - Recruiting

  • Parkinson?s Research Centers of America ? Palo Alto

    Palo Alto, California 94301
    United States

    Active - Recruiting

  • Profound Research LLC at The Neurology Center of Southern California

    Pasadena, California 91105
    United States

    Active - Recruiting

  • UCSF Weill Institute for Neurosciences

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Neurology Center of North Orange County

    Fullerton 5351247, California 5332921 92835
    United States

    Site Not Available

  • Keck School of Medicine of USC

    Los Angeles 5368361, California 5332921 900033
    United States

    Site Not Available

  • Profound Research LLC at The Neurology Center of Southern California

    Pasadena 5381396, California 5332921 91105
    United States

    Site Not Available

  • UCSF Weill Institute for Neurosciences

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • Rocky Mountain Movement Disorders

    Englewood, Colorado 80113
    United States

    Active - Recruiting

  • Rocky Mountain Movement Disorders

    Englewood 5421250, Colorado 5417618 80113
    United States

    Site Not Available

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Institute for Neurodegenerative Disorders

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • JEM Research LLC

    Atlantis, Florida 33462
    United States

    Active - Recruiting

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • K2 - Villages

    Lady Lake, Florida 32159
    United States

    Active - Recruiting

  • K2 Medical Research-Maitland

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Charter Research - Winter Park/Orlando

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • JEM Research LLC

    Atlantis 4146372, Florida 4155751 33462
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Site Not Available

  • K2 - Villages

    Lady Lake 4161118, Florida 4155751 32159
    United States

    Site Not Available

  • K2 Medical Research-Maitland

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • Charter Research - Winter Park/Orlando

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • Hawaii Pacific Neuroscience

    Honolulu 5856195, Hawaii 5855797 96817
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Site Not Available

  • Washington Uni School of Medicine

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Renown Health

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Dent Neurological Institute

    Amherst, New York 14226
    United States

    Active - Recruiting

  • Parkinson's Research Centers of America - Long Island

    Commack, New York 11725
    United States

    Active - Recruiting

  • Weill Cornell Medical College

    New York, New York 10021
    United States

    Active - Recruiting

  • Dent Neurological Institute

    Amherst 5107129, New York 5128638 14226
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • NeuroCare Center

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • NeuroCare Center

    Canton 5149222, Ohio 5165418 44718
    United States

    Site Not Available

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • The Movement Disorder Clinic of Oklahoma

    Tulsa 4553433, Oklahoma 4544379 74136
    United States

    Site Not Available

  • Veracity Neuroscience

    Memphis, Tennessee 38157
    United States

    Active - Recruiting

  • Texas Neurology PA

    Dallas, Texas 75206
    United States

    Active - Recruiting

  • Central Texas Neurology Consultants

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • Central Texas Neurology Consultants

    Round Rock 4724129, Texas 4736286 78681
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Site Not Available

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