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New drug aims to slow Parkinson's progression in early stages

NCT ID NCT04777331

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether prasinezumab, given as an IV infusion every 4 weeks, can slow motor decline in people with early Parkinson's disease. The study includes 586 participants who are already on stable Parkinson's medication. Researchers are measuring how long it takes for motor symptoms to worsen, comparing the drug against a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
prasinezumab
What this could lead to
If it works, this could slow the worsening of motor symptoms in early Parkinson's disease, giving patients more time with better movement control.
What could go wrong
This is a phase 2 trial, so results are still early. The drug may not slow progression more than placebo, and IV infusions carry risks like infusion reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

586 people

The number who actually took part.

Started

May 2021

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinsons disease

Contacts and locations

Locations

  • A.O. Universitaria Pisana

    Pisa, Tuscany, 56126, Italy

  • A.O.U. Policlinico "G.Rodolico - San Marco"

    Catania, Sicily, 95123, Italy

  • AO di Perugia - Ospedale S. Maria della Misericordia

    Perugia, Umbria, 06156, Italy

  • Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona

    Salerno, Campania, 84131, Italy

  • Azienda Ospedaliera S. Maria

    Terni, Umbria, 05100, Italy

  • Azienda Ospedaliera Spedali Civili

    Brescia, Lombardy, 25100, Italy

  • Azienda Ospedaliera di Padova

    Padova, Veneto, 35128, Italy

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030, United States

  • CHU Gui de Chauliac

    Montpellier, 34000, France

  • CHU Poitiers

    Poitiers, 86021, France

  • CHU Rouen Charles Nicolle

    Rouen, 76031, France

  • CHU Strasbourg Hpital Hautepierre

    Strasbourg, 67098, France

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, 87042, France

  • CHU de Nantes - Hopital Laennec

    Saint-Herblain, 44800, France

  • CHU de Nice Hopital Pasteur

    Nice, 06002, France

  • CIC - Hôpital Purpan

    Toulouse, 31059, France

  • Campus for Ageing and Vitality

    Newcastle, NE4 5PL, United Kingdom

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado, 80113, United States

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681, United States

  • Centre Hospitalier de Luxembourg

    Luxembourg, 1210, Luxembourg

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-684, Poland

  • Charing Cross Hospital

    London, W6 8RF, United Kingdom

  • Charter Research - Winter Park/Orlando

    Winter Park, Florida, 32792, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinique Neuro Outaouais

    Gatineau, Quebec, J8Y 1W2, Canada

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, LA Coruna, 15006, Spain

  • Dent Neurological Institute

    Amherst, New York, 14226, United States

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • EvergreenHealth Investigational Drug Services

    Kirkland, Washington, 98034, United States

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33000, France

  • Groupement Hospitalier Est - Hôpital Neurologique

    Bron, 69677, France

  • HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);

    Móstoles, Madrid, 28938, Spain

  • Henry Ford Hospital

    West Bloomfield, Michigan, 48322, United States

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • Hopital Pitie-Salpetriere APHP

    Paris, 75013, France

  • Hospital Clinic Servicio de Neurologia

    Barcelona, 08036, Spain

  • Hospital General De Catalunya

    Sant Cugat del Vallès, Barcelona, 8195, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203, Spain

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010, Spain

  • Hospital Ruber Juan Bravo

    Madrid, 28006, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario Dr. Peset

    Valencia, 46017, Spain

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario de Burgos. Servicio de Neurología

    Burgos, 09006, Spain

  • Hospital Universitario de la Princesa

    Madrid, 28006, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Virgen del Puerto

    Plasencia, Palencia, 10600, Spain

  • Hospital Virgen del Rocío

    Seville, 41013, Spain

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Hôpital Henri Mondor

    Créteil, 94000, France

  • Hôpital Michallon - Centre d'Investigation Clinique

    Grenoble, 38043, France

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy, 20133, Italy

  • IRCCS Neuromed

    Pozzilli (IS), Molise, 86077, Italy

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • IRCCS San Raffaele;Clinical Trial Center

    Rome, Lazio, 00166, Italy

  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

    Lublin, 20-016, Poland

  • Inland Northwest Research

    Spokane, Washington, 99202, United States

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510, United States

  • Irccs A.O.U.San Martino Ist

    Genoa, Liguria, 16132, Italy

  • JEM Research LLC

    Atlantis, Florida, 33462, United States

  • Keck School of Medicine of USC

    Los Angeles, California, 90033, United States

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Klinik Ottakring

    Vienna, 1160, Austria

  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

    Krakow, 31-505, Poland

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114-2759, United States

  • Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.

    Warsaw, 03-242, Poland

  • Medizinische Universität Graz

    Graz, 8036, Austria

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4, Canada

  • NZOZ Vitamed

    Bydgoszcz, 85-079, Poland

  • NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki

    ?ód?, 90-640, Poland

  • Neurology Center of North Orange County

    Fullerton, California, 92835, United States

  • Ninewells Hospital, Dundee- Scotland

    Dundee, DD2 1SY, United Kingdom

  • Nmedis sp. z o.o.

    Rzeszów, 35-232, Poland

  • North West Anglia NHS Foundation Trust

    Peterborough, PE3 9GZ, United Kingdom

  • Northwestern University Feinberg School Of Medicine

    Chicago, Illinois, 60611, United States

  • Ospedale Bellaria

    Bologna, Emilia-Romagna, 40139, Italy

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE, United Kingdom

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486, United States

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168, Italy

  • Policlínica Guipuzkoa

    Donosti-San Sebastián, Guipuzcoa, 20014, Spain

  • Quest Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Renstar Medical Research

    Ocala, Florida, 34470, United States

  • Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego

    Warsaw, 00-416, Poland

  • Sentara Neurology Specialists

    Norfolk, Virginia, 23507, United States

  • Servicio de Neurología Hospital Viamed Montecanal.

    Zaragoza, 50012, Spain

  • Southern Illinois University, School of Medicine

    Springfield, Illinois, 62702, United States

  • Szpital Sw. Wojciecha

    Gda?sk, 80-462, Poland

  • Texas Neurology PA

    Dallas, Texas, 75206, United States

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136, United States

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7, Canada

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8, Canada

  • UC San Diego

    La Jolla, California, 92037, United States

  • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck

    Innsbruck, 6020, Austria

  • University Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of South Florida

    Tampa, Florida, 33613-4706, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • Università degli studi della Campania Luigi Vanvitelli

    Naples, Campania, 80138, Italy

  • hopital de la Timone

    Marseille, 13385, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.