Recruiting
Phase 3

Prasinezumab

Sponsor:

Hoffmann-La Roche

Code:

NCT07174310

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Prasinezumab

Placebo

Study Details

Brief summary:

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.

Conditions

Parkinson's Disease

Study ID

NCT07174310

Start date

Nov 24, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2031

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prasinezumab

Participants will receive Prasinezumab as an IV infusion in the double blind treatment period. Upon completion, eligible participants will enter into the Open Label Extension (OLE) phase.

experimental: Placebo

Participants will receive placebo as an IV Infusion.

Interventions

Prasinezumab

Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.

Placebo

Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol

Primary outcome measure

  • Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score [ Time Frame: Up to at least Week 104 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Barrow Neurological Institute

Recruiting

Phoenix, Arizona, United States, 85013

Neurology Center of North Orange County

Recruiting

Fullerton, California, United States, 92835

UC San Diego

Recruiting

La Jolla, California, United States, 92037

Keck School of Medicine of USC

Recruiting

Los Angeles, California, United States, 900033

UCLA Neurology Outpatient Clinic

Recruiting

Los Angeles, California, United States, 90095

Parkinson?s Research Centers of America ? Palo Alto

Recruiting

Palo Alto, California, United States, 94301

Profound Research LLC at The Neurology Center of Southern California

Recruiting

Pasadena, California, United States, 91105

UCSF Weill Institute for Neurosciences

Recruiting

San Francisco, California, United States, 94158

Stanford Neuroscience Health Center (SNHC)

Recruiting

Stanford, California, United States, 94304

Rocky Mountain Movement Disorders

Recruiting

Englewood, Colorado, United States, 80113

Institute for Neurodegenerative Disorders

Recruiting

New Haven, Connecticut, United States, 06510

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20007

JEM Research LLC

Recruiting

Atlantis, Florida, United States, 33462

Parkinson's Disease and Movement Disorders Center of Boca Raton

Recruiting

Boca Raton, Florida, United States, 33486

K2 - Villages

Recruiting

Lady Lake, Florida, United States, 32159

K2 Medical Research-Maitland

Recruiting

Maitland, Florida, United States, 32751

Baptist Hospital of Miami

Recruiting

Miami, Florida, United States, 33176

Charter Research - Winter Park/Orlando

Recruiting

Orlando, Florida, United States, 32803

Advent Health Orlando

Recruiting

Orlando, Florida, United States, 32804

Hawaii Pacific Neuroscience

Recruiting

Honolulu, Hawaii, United States, 96817

Northwestern University Feinberg School Of Medicine

Recruiting

Chicago, Illinois, United States, 60611

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Quest Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Washington Uni School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Cleveland Clinic Lou Ruvo

Recruiting

Las Vegas, Nevada, United States, 89106

Renown Health

Recruiting

Reno, Nevada, United States, 89502

Hackensack University Medical Center;Department of Neurology, Neuroscience Institute

Recruiting

Paramus, New Jersey, United States, 07652

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87106

Dent Neurological Institute

Recruiting

Amherst, New York, United States, 14226

Parkinson's Research Centers of America - Long Island

Recruiting

Commack, New York, United States, 11725

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Asheville Neurology

Recruiting

Asheville, North Carolina, United States, 28806

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

NeuroCare Center

Recruiting

Canton, Ohio, United States, 44718

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

The Movement Disorder Clinic of Oklahoma

Recruiting

Tulsa, Oklahoma, United States, 74136

University Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Avera Medical Group

Recruiting

Sioux Falls, South Dakota, United States, 57105

Veracity Neuroscience

Recruiting

Memphis, Tennessee, United States, 38157

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Texas Neurology PA

Recruiting

Dallas, Texas, United States, 75206

Central Texas Neurology Consultants

Recruiting

Round Rock, Texas, United States, 78681

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22903

VCU Health North Hospital

Recruiting

Richmond, Virginia, United States, 23298

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

CHUM

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Montreal Neurological Institute and Hospital

Recruiting

Montreal, Quebec, Canada, H3A 2B4

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-06.