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A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
Sponsor: Hoffmann-La Roche
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
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Prasinezumab
Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
Placebo
Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol
Locations (101)
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
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
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
Renown Health
Reno, Nevada, 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
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
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
Klinik Ottakring
Vienna, Austria
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Núcleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisas Clinicas
São Paulo, São Paulo, Brazil
CHUM
Montreal, Quebec, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
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
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Nanjing Brain Hospital
Nanjing, China
The Second Affiliated Hospital of Suzhou University
Suzhou, China
Aarhus Universitetshospital Skejby
Aarhus N, Denmark
Bispebjerg Hospital;Neurologisk Afdeling
København NV, Denmark
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
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
Irccs A.O.U.San Martino Ist
Genoa, Liguria, Italy
IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy
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
Seoul National University Hospital
Seoul, South Korea
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
Changhua Christian Hospital
Changhua County, Taiwan
China Medical University Hospital
North Dist., 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