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A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
NCT07174310 · Hoffmann-La Roche
In plain English
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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
About this study
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 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
Study design
Enrollment target: 900 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-11-24
Estimated completion: 2031-06-30
Last updated: 2026-04-06
Interventions
Drug: PrasinezumabDrug: Placebo
Primary outcomes
- • Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score (Up to at least Week 104)
Sponsor
Hoffmann-La Roche · industry
With: Prothena Biosciences Limited
Contacts & investigators
ContactReference Study ID Number: BN44715 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. and Canada)
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (101)
Neurology Center of North Orange CountyRecruiting
Fullerton, California, United States
Keck School of Medicine of USCRecruiting
Los Angeles, California, United States
Parkinson?s Research Centers of America ? Palo AltoRecruiting
Palo Alto, California, United States
Profound Research LLC at The Neurology Center of Southern CaliforniaRecruiting
Pasadena, California, United States
UCSF Weill Institute for NeurosciencesRecruiting
San Francisco, California, United States
Rocky Mountain Movement DisordersRecruiting
Englewood, Colorado, United States
Institute for Neurodegenerative DisordersRecruiting
New Haven, Connecticut, United States
JEM Research LLCRecruiting
Atlantis, Florida, United States
Parkinson's Disease and Movement Disorders Center of Boca RatonRecruiting
Boca Raton, Florida, United States
K2 - VillagesRecruiting
Lady Lake, Florida, United States
K2 Medical Research-MaitlandRecruiting
Maitland, Florida, United States
Charter Research - Winter Park/OrlandoRecruiting
Orlando, Florida, United States
Hawaii Pacific NeuroscienceRecruiting
Honolulu, Hawaii, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Quest Research InstituteRecruiting
Farmington Hills, Michigan, United States
Washington Uni School of MedicineRecruiting
St Louis, Missouri, United States
Renown HealthRecruiting
Reno, Nevada, United States
Dent Neurological InstituteRecruiting
Amherst, New York, United States
Parkinson's Research Centers of America - Long IslandRecruiting
Commack, New York, United States
Weill Cornell Medical CollegeRecruiting
New York, New York, United States
NeuroCare CenterRecruiting
Canton, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
The Movement Disorder Clinic of OklahomaRecruiting
Tulsa, Oklahoma, United States
Veracity NeuroscienceRecruiting
Memphis, Tennessee, United States
Texas Neurology PARecruiting
Dallas, Texas, United States
Central Texas Neurology ConsultantsRecruiting
Round Rock, Texas, United States
University of Virginia Health SystemRecruiting
Charlottesville, Virginia, United States
West Virginia UniversityRecruiting
Morgantown, West Virginia, United States
Southern NeurologyRecruiting
Kogarah, New South Wales, Australia
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Monash HealthRecruiting
Clayton, Victoria, Australia
The Alfred HospitalRecruiting
Prahan, Victoria, Australia
Perron Institute for Neurological and Translational ScienceRecruiting
Nedlands, Western Australia, Australia
Medizinische Universität GrazRecruiting
Graz, Austria
Uniklinik fuer Neurologie, Medizinische Universitaet InnsbruckRecruiting
Innsbruck, Austria
Kepler Universitätsklinikum GmbH - Neuromed CampusRecruiting
Linz, Austria
Klinik OttakringRecruiting
Vienna, Austria
Instituto de Neurologia de CuritibaRecruiting
Curitiba, Paraná, Brazil
Núcleo de Pesquisa do Rio Grande do SulRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisas ClinicasRecruiting
São Paulo, São Paulo, Brazil
CHUMRecruiting
Montreal, Quebec, Canada
Montreal Neurological Institute and HospitalRecruiting
Montreal, Quebec, Canada
Beijing Friendship Hospital Affiliated of Capital University of Medical ScienceRecruiting
Beijing, China
The First Hospital of Jilin UniversityRecruiting
Changchun, China
West China Hospital of Sichuan UniversityRecruiting
Chengdu, China
The First Affiliated Hospital, Chongqing Medical UniversityRecruiting
Chongqing, China
Fujian Medical University Union HospitalRecruiting
Fuzhou, China
The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Guangzhou, China
The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Hangzhou, China
Nanjing Brain HospitalRecruiting
Nanjing, China
The Second Affiliated Hospital of Suzhou UniversityRecruiting
Suzhou, China
Aarhus Universitetshospital SkejbyRecruiting
Aarhus N, Denmark
Bispebjerg Hospital;Neurologisk AfdelingRecruiting
København NV, Denmark
Heinrich-Heine Universitätsklinik DüsseldorfRecruiting
Düsseldorf, Germany
Universitätsklinikum Erlangen, Abteilung Molekulare NeurologieRecruiting
Erlangen, Germany
Paracelsus Elena Klinik KasselRecruiting
Kassel, Germany
Klinikum rechts der Isar der TU MünchenRecruiting
Munich, Germany
Università degli studi della Campania Luigi VanvitelliRecruiting
Naples, Campania, Italy
Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' AragonaRecruiting
Salerno, Campania, Italy
Irccs A.O.U.San Martino IstRecruiting
Genoa, Liguria, Italy
IRCCS Istituto Neurologico Carlo BestaRecruiting
Milan, Lombardy, Italy
Hospital General de MexicoRecruiting
Mexico City, Mexico CITY (federal District), Mexico
Podlaskie Centrum PsychogeriatriiRecruiting
Bia?ystok, Poland
NZOZ VitamedRecruiting
Bydgoszcz, Poland
Szpital Sw. WojciechaRecruiting
Gda?sk, Poland
NEURO-CARE Sp. z o.o. Sp. KomandytowaRecruiting
Katowice, Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii KRecruiting
Krakow, Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.Recruiting
Lublin, Poland
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.Recruiting
Oświęcim, Poland
Nmedis sp. z o.o.Recruiting
Rzeszów, Poland
NeuroProtectRecruiting
Warsaw, Poland
Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.Recruiting
Warsaw, Poland
Hospital de BragaRecruiting
Braga, Portugal
Hospital da Luz CoimbraRecruiting
Coimbra, Portugal
Hospital Dr. Nélio Mendonça;Serviço de NeurologiaRecruiting
Funchal, Portugal
Hospital Pedro HispanoRecruiting
Matosinhos Municipality, Portugal
CNS - Campus NeurológicoRecruiting
Torres Vedras, Portugal
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Hospital General De CatalunyaRecruiting
Sant Cugat del Vallès, Barcelona, Spain
Policlinica GuipuzcoaRecruiting
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital Universitario Fundación AlcorcónRecruiting
Alcorcón, Madrid, Spain
Hospital Quiron de MadridRecruiting
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitari Vall d HebronRecruiting
Barcelona, Spain
Hospital Clinic BarcelonaRecruiting
Barcelona, Spain
Hospital Ruber Juan BravoRecruiting
Madrid, Spain
Hospital Universitario de La PrincesaRecruiting
Madrid, Spain
Hospital Univ 12 de OctubreRecruiting
Madrid, Spain
Changhua Christian HospitalRecruiting
Changhua County, Taiwan
China Medical University HospitalRecruiting
North Dist., Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Ninewells Hospital, Dundee- ScotlandRecruiting
Dundee, United Kingdom
Royal Devon and Exeter Hospital (Wonford)Recruiting
Exeter, United Kingdom
Royal London HospitalRecruiting
London, United Kingdom
Charing Cross HospitalRecruiting
London, United Kingdom
Campus for Ageing and VitalityRecruiting
Newcastle, United Kingdom
Oxford University Hospitals NHS Foundation TrustRecruiting
Oxford, United Kingdom
Plymouth Hospitals NHS Trust - Derriford HospitalRecruiting
Plymouth,Devon, United Kingdom