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Clinical Trials in the UK / NCT04777331
Active, not recruiting Phase 2

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

NCT04777331 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2021-05-05
Last updated
2026-09-04

Condition(s) studied

Parkinsons Disease

Investigational drug(s) / intervention(s)

PrasinezumabPlacebo

Prasinezumab: Prasinezumab will be administered as an IV infusion to participants Q4W.

Placebo: Prasinezumab placebo will be administered to participants.

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (110)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Barrow Neurological Institute Phoenix Arizona
Neurology Center of North Orange County Fullerton California
UC San Diego La Jolla California
Keck School of Medicine of USC Los Angeles California
Cedars Sinai Medical Center Los Angeles California
University of California San Francisco San Francisco California
CenExel Rocky Mountain Clinical Research, LLC Englewood Colorado
Institute for Neurodegenerative Disorders New Haven Connecticut
JEM Research LLC Atlantis Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton Florida
Renstar Medical Research Ocala Florida
University of South Florida Tampa Florida
Charter Research - Winter Park/Orlando Winter Park Florida
Northwestern University Feinberg School Of Medicine Chicago Illinois
Southern Illinois University, School of Medicine Springfield Illinois
University of Kansas Medical Center Kansas City Kansas
Massachusetts General Hospital Boston Massachusetts
Quest Research Institute Farmington Hills Michigan
Henry Ford Hospital West Bloomfield Michigan
Dent Neurological Institute Amherst New York
Cleveland Clinic Cleveland Ohio
The Movement Disorder Clinic of Oklahoma Tulsa Oklahoma
University Pennsylvania Hospital Philadelphia Pennsylvania
Texas Neurology PA Dallas Texas
Baylor College of Medicine Medical Center Houston Texas
Central Texas Neurology Consultants Round Rock Texas
University of Vermont Medical Center Burlington Vermont
Sentara Neurology Specialists Norfolk Virginia
EvergreenHealth Investigational Drug Services Kirkland Washington
Inland Northwest Research Spokane Washington
Medizinische Universität Graz Graz Austria
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck Innsbruck Austria
Klinik Ottakring Vienna Austria
Toronto Memory Program Toronto Ontario
Toronto Western Hospital Toronto Ontario
Clinique Neuro Outaouais Gatineau Quebec
Montreal Neurological Institute and Hospital Montreal Quebec
Groupe Hospitalier Pellegrin Bordeaux France
Groupement Hospitalier Est - Hôpital Neurologique Bron France

+ 70 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04777331 on ClinicalTrials.gov ↗ ← All trials in the UK