A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
NCT ID: NCT04777331
Last Updated: 2025-12-26
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
586 participants
INTERVENTIONAL
2021-05-05
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Prasinezumab
Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W).
Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed.
Prasinezumab
Prasinezumab will be administered as an IV infusion to participants Q4W.
Placebo
Participants will receive placebo as an IV infusion Q4W.
Placebo
Prasinezumab placebo will be administered to participants.
Interventions
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Prasinezumab
Prasinezumab will be administered as an IV infusion to participants Q4W.
Placebo
Prasinezumab placebo will be administered to participants.
Eligibility Criteria
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Inclusion Criteria
* On symptomatic PD medication, with stable doses for at least 3 months prior to baseline
* A diagnosis of PD for at least 3 months to maximum 3 years at screening
* MDS-UPDRS Part IV score of 0 at screening and prior to randomization
* Hoehn and Yahr (H\&Y) Stage I or II in OFF medication state at screening and prior to randomization
* Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader
* No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening
* Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study
* Willingness and ability to wear a smartwatch to measure PD-related motor signs
Exclusion Criteria
* Diagnosis of PD dementia
* Diagnosis of a significant neurologic disease other than PD
* Within the last year, unstable or clinically significant cardiovascular disease
* Uncontrolled hypertension
* Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)
* Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis
* Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody
* Any contraindications to obtaining a brain magnetic resonance imaging (MRI)
* Any contraindications to DaT-SPECT imaging
50 Years
85 Years
ALL
No
Sponsors
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Prothena Biosciences Limited
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
CenExel Rocky Mountain Clinical Research, LLC
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
Renstar Medical Research
Ocala, Florida, United States
University of South Florida
Tampa, Florida, United States
Charter Research - Winter Park/Orlando
Winter Park, Florida, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
Southern Illinois University, School of Medicine
Springfield, 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
Henry Ford Hospital
West Bloomfield, Michigan, United States
Dent Neurological Institute
Amherst, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
University Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Texas Neurology PA
Dallas, Texas, United States
Baylor College of Medicine Medical Center
Houston, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Sentara Neurology Specialists
Norfolk, Virginia, United States
EvergreenHealth Investigational Drug Services
Kirkland, Washington, United States
Inland Northwest Research
Spokane, Washington, United States
Medizinische Universität Graz
Graz, , Austria
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck
Innsbruck, , Austria
Klinik Ottakring
Vienna, , Austria
Toronto Memory Program
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Clinique Neuro Outaouais
Gatineau, Quebec, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Groupe Hospitalier Pellegrin
Bordeaux, , France
Groupement Hospitalier Est - Hôpital Neurologique
Bron, , France
Hopital Gabriel Montpied
Clermont-Ferrand, , France
Hôpital Henri Mondor
Créteil, , France
Hôpital Michallon - Centre d'Investigation Clinique
Grenoble, , France
CHU de Limoges - Hôpital Dupuytren
Limoges, , France
hopital de la Timone
Marseille, , France
CHU Gui de Chauliac
Montpellier, , France
CHU de Nice Hopital Pasteur
Nice, , France
Hopital Pitie-Salpetriere APHP
Paris, , France
CHU Poitiers
Poitiers, , France
CHU Rouen Charles Nicolle
Rouen, , France
CHU de Nantes - Hopital Laennec
Saint-Herblain, , France
CHU Strasbourg Hpital Hautepierre
Strasbourg, , France
CIC - Hôpital Purpan
Toulouse, , France
Università degli studi della Campania Luigi Vanvitelli
Napoli, Campania, Italy
Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona
Salerno, Campania, Italy
Ospedale Bellaria
Bologna, Emilia-Romagna, Italy
IRCCS San Raffaele;Clinical Trial Center
Rome, Lazio, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
Irccs A.O.U.San Martino Ist
Genoa, Liguria, Italy
Azienda Ospedaliera Spedali Civili
Brescia, Lombardy, Italy
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy
IRCCS Neuromed
Pozzilli (IS), Molise, Italy
A.O.U. Policlinico "G.Rodolico - San Marco"
Catania, Sicily, Italy
A.O. Universitaria Pisana
Pisa, Tuscany, Italy
AO di Perugia - Ospedale S. Maria della Misericordia
Perugia, Umbria, Italy
Azienda Ospedaliera S. Maria
Terni, Umbria, Italy
Azienda Ospedaliera di Padova
Padua, Veneto, Italy
Centre Hospitalier de Luxembourg
Luxembourg, , Luxembourg
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
?ód?, , Poland
NZOZ Vitamed
Bydgoszcz, , Poland
Szpital Sw. Wojciecha
Gda?sk, , 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
Nmedis sp. z o.o.
Rzeszów, , Poland
Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego
Warsaw, , Poland
Centrum Medyczne NeuroProtect
Warsaw, , Poland
Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.
Warsaw, , Poland
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital General De Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Policlínica Guipuzkoa
Donosti-San Sebastián, Guipuzcoa, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);
Móstoles, Madrid, Spain
Hospital Quiron de Madrid
Pozuelo de Alarcón, Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Virgen del Puerto
Plasencia, Palencia, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clinic Servicio de Neurologia
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario de Burgos. Servicio de Neurología
Burgos, , Spain
Hospital Ruber Juan Bravo
Madrid, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Servicio de Neurología Hospital Viamed Montecanal.
Zaragoza, , Spain
Ninewells Hospital, Dundee- Scotland
Dundee, , United Kingdom
Kings College 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
North West Anglia NHS Foundation Trust
Peterborough, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-004997-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-507132-21-00
Identifier Type: CTIS
Identifier Source: secondary_id
BN42358
Identifier Type: -
Identifier Source: org_study_id