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

Hoffmann-La Roche

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 range: 50–85 years
Sex: All
Healthy volunteers: No

Detailed criteria

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 fr…

Interventions

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

Locations (192)

University of Alabama at Birmingham
Birmingham, Alabama
Barrow Neurological Institute
Phoenix, Arizona
Neurology Center of North Orange County
Fullerton, California
UC San Diego
La Jolla, California
Keck School of Medicine of USC
Los Angeles, California
UCLA Neurology Outpatient Clinic
Los Angeles, California