A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
NCT07174310 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900
Last updated 2026-05-06
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
Interventions
- DRUG
-
Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
- DRUG
-
Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol
Sponsors & Collaborators
-
Prothena Biosciences Limited
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-24
- Primary Completion
- 2029-06-30
- Completion
- 2031-06-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- Brazil
- Canada
- China
- Denmark
- France
- Germany
- Italy
- Mexico
- Poland
- Portugal
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
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