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

RECRUITINGPHASE3

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

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

NCT07174310•Hoffmann-La Roche

View on ClinicalTrials.gov

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

Age

50 - 85 years

Sex

ALL

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

Locations (66)

Neurology Center of North Orange County

Fullerton, California, United States

Keck School of Medicine of USC

Los Angeles, California, United States

Profound Research LLC at The Neurology Center of Southern California

Pasadena, California, United States

UCSF Weill Institute for Neurosciences

San Francisco, California, United States

Rocky Mountain Movement Disorders

Englewood, Colorado, United States

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

JEM Research LLC

Atlantis, Florida, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

K2 - Villages

Lady Lake, Florida, United States

K2 Medical Research-Maitland

Maitland, Florida, United States

Key Dates

Start Date

November 24, 2025

Primary Completion Date

June 30, 2029

Completion Date

June 30, 2031

Last Updated

March 9, 2026

Enrollment

900

ESTIMATED participants

Conditions

Parkinson's Disease

Interventions

Prasinezumab

DRUG

Placebo

DRUG

Contacts

Reference Study ID Number: BN44715 https://forpatients.roche.com/

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

LIFUS For Neurological Disorders