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
- Diseases
- Parkinson disease
- 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
Sites (110)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Active, not recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Active, not recruiting |
| Stadt Wien Wiener Gesundheitsverbund Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| Clinique Neuro-Outaouais Coordinator of this site? Confirm its status | Gatineau | Canada | Unknown status |
| Montreal Neurological Institute and Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Toronto Western Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Toronto Memory Program Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Hospital Universitario Fundación Alcorcón Coordinator of this site? Confirm its status | Alcorcón | Spain | Active, not recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Active, not recruiting |
| Policlinica Gipuzkoa S.A. Coordinator of this site? Confirm its status | Donostia | Spain | Active, not recruiting |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Active, not recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Ruber Juan Bravo Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario HM Puerta del Sur Coordinator of this site? Confirm its status | Móstoles | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Virgen del Puerto Coordinator of this site? Confirm its status | Plasencia | Spain | Active, not recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Active, not recruiting |
| Hospital Universitari General de Catalunya Coordinator of this site? Confirm its status | Sant Cugat del Vallès | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Dr. Peset Aleixandre Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Clinica Montecanal S.L. Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Active, not recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont Ferrand Cedex 1 | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil | France | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Et Universitaire De Limoges Coordinator of this site? Confirm its status | Limoges Cedex 1 | France | Active, not recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Active, not recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Active, not recruiting |
| Ninewells Hospital, Dundee- Scotland Coordinator of this site? Confirm its status | Dundee | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Charing Cross Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Campus for Ageing and Vitality Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| North West Anglia NHS Foundation Trust Coordinator of this site? Confirm its status | Peterborough | United Kingdom | Unknown status |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Active, not recruiting |
| IRCCS Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Istituto Neurologico Mediterraneo Neuromed S.p.A. Coordinator of this site? Confirm its status | Pozzilli | Italy | Active, not recruiting |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona Coordinator of this site? Confirm its status | Salerno | Italy | Active, not recruiting |
| Azienda Ospedaliera S Maria Di Terni Coordinator of this site? Confirm its status | Terni | Italy | Active, not recruiting |
| Centre hospitalier de Luxembourg Coordinator of this site? Confirm its status | Luxembourg | Luxembourg | Active, not recruiting |
| Vitamed Galaj i Cichomski sp.j. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Krakowska Akademia Neurologii Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Nmedis sp. z o.o. Coordinator of this site? Confirm its status | Rzeszów | Poland | Active, not recruiting |
| Mazowiecki Szpital Brodnowski Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Centrum Medyczne NeuroProtect Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Dent Neurological Institute Coordinator of this site? Confirm its status | Amherst | United States | Unknown status |
| JEM Research LLC Coordinator of this site? Confirm its status | Atlantis | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Parkinson's Disease and Movement Disorders Center of Boca Raton Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Vermont Medical Center Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Northwestern University Feinberg School of Medicine Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Texas Neurology, PA Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| CenExel Rocky Mountain Clinical Research, LLC Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| Neurology Center of North Orange County Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Baylor College of Medicine Medical Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| EvergreenHealth Investigational Drug Services Coordinator of this site? Confirm its status | Kirkland | United States | Unknown status |
| UC San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Keck School of Medicine of USC Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Institute for Neurodegenerative Disorders Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Sentara Neurology Specialists Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Renstar Medical Research Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| University Pennsylvania Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Barrow Neurological Institute Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Central Texas Neurology Consultants Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Inland Northwest Research Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Southern Illinois University School of Medicine Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| The Movement Disorder Clinic of Oklahoma Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | West Bloomfield | United States | Unknown status |
| Charter Research - Winter Park/Orlando Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.