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NCT04777331Active, not recruitingPhase 2

A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

Source: ClinicalTrials.gov · Last updated 4 Sept 2026

Brief summary (registry, in English)

This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
586 (actual)
First submitted
26 Feb 2021
Start date
5 May 2021
Primary completion date
11 Sept 2024
Lead sponsor
Hoffmann-La Roche
NCT number
NCT04777331
EU CT number
2023-507132-21-00
EudraCT number
2020-004997-23

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 586
  • From 5 May 2021 to the primary completion date, 11 Sept 2024
  • 110 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)
  • Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody

Other illness

  • Medical history indicating a Parkinsonian syndrome other than idiopathic PD
  • 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

Lab values

  • Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis

Other

  • Any contraindications to obtaining a brain magnetic resonance imaging (MRI)
  • Any contraindications to DaT-SPECT imaging

Who the study is looking for

  • Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
  • 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

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (110)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaActive, not recruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Stadt Wien Wiener Gesundheitsverbund
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ViennaAustriaActive, not recruiting
Clinique Neuro-Outaouais
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GatineauCanadaUnknown status
Montreal Neurological Institute and Hospital
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MontrealCanadaUnknown status
Toronto Western Hospital
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TorontoCanadaUnknown status
Toronto Memory Program
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TorontoCanadaUnknown status
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainActive, not recruiting
Hospital Universitario de Cruces
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BarakaldoSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario De Burgos
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BurgosSpainActive, not recruiting
Policlinica Gipuzkoa S.A.
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DonostiaSpainActive, not recruiting
Hospital General Universitario de Elche
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ElcheSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
Hospital Ruber Juan Bravo
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario de la Princesa
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Hospital Universitario HM Puerta del Sur
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MóstolesSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Virgen del Puerto
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PlasenciaSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Hospital Universitari General de Catalunya
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Sant Cugat del VallèsSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Hospital Universitario Dr. Peset Aleixandre
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ValenciaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Clinica Montecanal S.L.
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ZaragozaSpainActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceActive, not recruiting
Hospices Civils de Lyon
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BronFranceActive, not recruiting
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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CreteilFranceActive, not recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceActive, not recruiting
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceActive, not recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceActive, not recruiting
Centre Hospitalier Universitaire Rouen
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Rouen CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceActive, not recruiting
Ninewells Hospital, Dundee- Scotland
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DundeeUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
Charing Cross Hospital
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LondonUnited KingdomUnknown status
Campus for Ageing and Vitality
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NewcastleUnited KingdomUnknown status
Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomUnknown status
North West Anglia NHS Foundation Trust
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PeterboroughUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyActive, not recruiting
IRCCS Azienda Ospedaliera Metropolitana
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GenoaItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyActive, not recruiting
Azienda Ospedaliera di Padova
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PadovaItalyActive, not recruiting
Hospital Santa Maria Della Misericordia
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PerugiaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Istituto Neurologico Mediterraneo Neuromed S.p.A.
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PozzilliItalyActive, not recruiting
Irccs San Raffaele Roma S.r.l.
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RomeItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
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SalernoItalyActive, not recruiting
Azienda Ospedaliera S Maria Di Terni
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TerniItalyActive, not recruiting
Centre hospitalier de Luxembourg
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LuxembourgLuxembourgActive, not recruiting
Vitamed Galaj i Cichomski sp.j.
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BydgoszczPolandActive, not recruiting
Krakowska Akademia Neurologii Sp. z o.o.
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CracowPolandActive, not recruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandActive, not recruiting
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
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LodzPolandActive, not recruiting
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
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LublinPolandActive, not recruiting
Nmedis sp. z o.o.
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RzeszówPolandActive, not recruiting
Mazowiecki Szpital Brodnowski Sp. z o.o.
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WarsawPolandActive, not recruiting
Centrum Medyczne NeuroProtect
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WarsawPolandActive, not recruiting
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP
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WarsawPolandActive, not recruiting
Dent Neurological Institute
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AmherstUnited StatesUnknown status
JEM Research LLC
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AtlantisUnited StatesUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Parkinson's Disease and Movement Disorders Center of Boca Raton
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Boca RatonUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
University of Vermont Medical Center
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BurlingtonUnited StatesUnknown status
Northwestern University Feinberg School of Medicine
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ChicagoUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Texas Neurology, PA
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DallasUnited StatesUnknown status
CenExel Rocky Mountain Clinical Research, LLC
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EnglewoodUnited StatesUnknown status
QUEST Research Institute
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Farmington HillsUnited StatesUnknown status
Neurology Center of North Orange County
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FullertonUnited StatesUnknown status
Baylor College of Medicine Medical Center
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HoustonUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
EvergreenHealth Investigational Drug Services
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KirklandUnited StatesUnknown status
UC San Diego
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La JollaUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Keck School of Medicine of USC
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Los AngelesUnited StatesUnknown status
Institute for Neurodegenerative Disorders
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New HavenUnited StatesUnknown status
Sentara Neurology Specialists
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NorfolkUnited StatesUnknown status
Renstar Medical Research
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OcalaUnited StatesUnknown status
University Pennsylvania Hospital
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PhiladelphiaUnited StatesUnknown status
Barrow Neurological Institute
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PhoenixUnited StatesUnknown status
Central Texas Neurology Consultants
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Round RockUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Inland Northwest Research
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SpokaneUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
University of South Florida
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TampaUnited StatesUnknown status
The Movement Disorder Clinic of Oklahoma
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TulsaUnited StatesUnknown status
Henry Ford Hospital
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West BloomfieldUnited StatesUnknown status
Charter Research - Winter Park/Orlando
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Winter ParkUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.