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

NCT07174310 · tracked via the Priya Life Science UK tracker

Sponsor

Hoffmann-La Roche

Phase

Phase 3

Started

2025-11-24

Last updated

2026-09-03

Condition(s) studied

Parkinson's Disease

Investigational drug(s) / intervention(s)

PrasinezumabPlacebo

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

Study 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.

Eligibility

Sex

ALL

Min age

50 Years

Max age

85 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (192)

Facility	City	Region	Status
University of Alabama at Birmingham	Birmingham	Alabama	Recruiting
Barrow Neurological Institute	Phoenix	Arizona	Recruiting
Neurology Center of North Orange County	Fullerton	California	Recruiting
UC San Diego	La Jolla	California	Recruiting
Keck School of Medicine of USC	Los Angeles	California	Recruiting
UCLA Neurology Outpatient Clinic	Los Angeles	California	Recruiting
Parkinson?s Research Centers of America ? Palo Alto	Palo Alto	California	Recruiting
Profound Research LLC at The Neurology Center of Southern California	Pasadena	California	Recruiting
UCSF Weill Institute for Neurosciences	San Francisco	California	Recruiting
Stanford Neuroscience Health Center (SNHC)	Stanford	California	Recruiting
Rocky Mountain Movement Disorders	Englewood	Colorado	Recruiting
Institute for Neurodegenerative Disorders	New Haven	Connecticut	Recruiting
Georgetown University	Washington D.C.	District of Columbia	Recruiting
JEM Research LLC	Atlantis	Florida	Recruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida	Recruiting
K2 - Villages	Lady Lake	Florida	Recruiting
K2 Medical Research-Maitland	Maitland	Florida	Recruiting
Baptist Hospital of Miami	Miami	Florida	Recruiting
Charter Research - Winter Park/Orlando	Orlando	Florida	Recruiting
Advent Health Orlando	Orlando	Florida	Recruiting
USF Parkinsons Disease and Movement Disorders Center	Tampa	Florida	Recruiting
Grady Memorial Hospital	Atlanta	Georgia	Recruiting
Hawaii Pacific Neuroscience	Honolulu	Hawaii	Recruiting
Northwestern University Feinberg School Of Medicine	Chicago	Illinois	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Quest Research Institute	Farmington Hills	Michigan	Recruiting
Washington Uni School of Medicine	St Louis	Missouri	Recruiting
Cleveland Clinic Lou Ruvo	Las Vegas	Nevada	Recruiting
Renown Health	Reno	Nevada	Recruiting
Hackensack University Medical Center;Department of Neurology, Neuroscience Institute	Paramus	New Jersey	Recruiting
University of New Mexico	Albuquerque	New Mexico	Recruiting
Dent Neurological Institute	Amherst	New York	Recruiting
Parkinson's Research Centers of America - Long Island	Commack	New York	Recruiting
Weill Cornell Medical College	New York	New York	Recruiting
Columbia University Medical Center	New York	New York	Recruiting
Asheville Neurology	Asheville	North Carolina	Recruiting
Duke University Medical Center	Durham	North Carolina	Recruiting
NeuroCare Center	Canton	Ohio	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting

+ 152 more sites — see the full list on the official registry below.

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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 NCT07174310 on ClinicalTrials.gov ↗ ← All trials in the UK