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A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

RecruitingPhase 3

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

Who can join

Ages 50 to 85 · All sexes

Full eligibility criteria

Inclusion Criteria:

* Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2
* Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
* Has received monotherapy treatment
* An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
* Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization
* Agreement to adhere to the contraception requirements

Exclusion Criteria:

* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
* Medical history indicating a parkinsonian syndrome other than idiopathic PD
* Diagnosis of a significant neurologic disease other than PD
* Chronic uncontrolled hypertension

About the study

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.

What is being tested

Prasinezumab (drug)
Placebo (drug)

Sponsor: Hoffmann-La Roche · Participants: 900 · Started: Nov 24, 2025

Contact the study team

Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below. · Phone: 888-662-6728 (U.S. and Canada)

Official record on ClinicalTrials.gov — NCT07174310

Locations in the U.S.

Alabama	University of Alabama at Birmingham, Birmingham
Arizona	Barrow Neurological Institute, Phoenix
California	Neurology Center of North Orange County, Fullerton UC San Diego, La Jolla Keck School of Medicine of USC, Los Angeles UCLA Neurology Outpatient Clinic, Los Angeles Parkinson?s Research Centers of America ? Palo Alto, Palo Alto Profound Research LLC at The Neurology Center of Southern California, Pasadena UCSF Weill Institute for Neurosciences, San Francisco Stanford Neuroscience Health Center (SNHC), Stanford
Colorado	Rocky Mountain Movement Disorders, Englewood
Connecticut	Institute for Neurodegenerative Disorders, New Haven
District of Columbia	Georgetown University, Washington D.C.
Florida	JEM Research LLC, Atlantis Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton K2 - Villages, Lady Lake K2 Medical Research-Maitland, Maitland Baptist Hospital of Miami, Miami Advent Health Orlando, Orlando Charter Research - Winter Park/Orlando, Orlando USF Parkinsons Disease and Movement Disorders Center, Tampa
Georgia	Grady Memorial Hospital, Atlanta
Hawaii	Hawaii Pacific Neuroscience, Honolulu
Illinois	Northwestern University Feinberg School Of Medicine, Chicago
Kansas	University of Kansas Medical Center, Kansas City
Massachusetts	Massachusetts General Hospital, Boston
Michigan	Quest Research Institute, Farmington Hills
Missouri	Washington Uni School of Medicine, St Louis
Nevada	Cleveland Clinic Lou Ruvo, Las Vegas Renown Health, Reno
New Jersey	Hackensack University Medical Center;Department of Neurology, Neuroscience Institute, Paramus
New Mexico	University of New Mexico, Albuquerque
New York	Dent Neurological Institute, Amherst Parkinson's Research Centers of America - Long Island, Commack Columbia University Medical Center, New York Weill Cornell Medical College, New York
North Carolina	Asheville Neurology, Asheville Duke University Medical Center, Durham
Ohio	NeuroCare Center, Canton Cleveland Clinic, Cleveland
Oklahoma	The Movement Disorder Clinic of Oklahoma, Tulsa
Oregon	Oregon Health and Science University, Portland
Pennsylvania	University Pennsylvania Hospital, Philadelphia Allegheny General Hospital, Pittsburgh
South Dakota	Avera Medical Group, Sioux Falls
Tennessee	Veracity Neuroscience, Memphis Vanderbilt University Medical Center, Nashville
Texas	Texas Neurology PA, Dallas Central Texas Neurology Consultants, Round Rock
Vermont	University of Vermont Medical Center, Burlington
Virginia	University of Virginia Health System, Charlottesville VCU Health North Hospital, Richmond
West Virginia	West Virginia University, Morgantown

Conditions

Parkinson's Disease

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.