NCT07174310

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Prasinezumab	Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
DRUG	Placebo	Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol

Timeline

• Start date: 2025-11-24
• Primary completion: 2029-06-30
• Completion: 2031-06-30
• First posted: 2025-09-15
• Last updated: 2026-04-06

Locations

101 sites across 16 countries: United States, Australia, Austria, Brazil, Canada, China, Denmark, Germany, Italy, Mexico, Poland, Portugal, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study