A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Early-Stage Parkinsons Disease

What this Trial Is About

Researchers are evaluating the efficacy, safety, and how the body processes pharmacokinetics prasinezumab compared with a placebo in people with early-stage Parkinsons disease who are already on stable levodopa treatment. This phase III study aims to better understand how prasinezumab affects the progression of motor symptoms in this population. Participants will be randomly assigned to receive either prasinezumab or placebo through intravenous IV infusions during a double-blind treatment period. After completing this phase, eligible participants can join an Open Label Extension OLE phase where they will receive prasinezumab. The treatments are given as scheduled IV infusions. During the study, participants will undergo regular assessments including evaluations of motor function using the Movement Disorder Society Unified Parkinsons Disease Rating Scale MDS-UPDRS Part III. Blood samples will be taken to measure drug levels and immune responses. Safety will be closely monitored, including tracking adverse events and infusion reactions. The primary outcome is the time until confirmed motor progression, with follow-up lasting up to at least 104 weeks.

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