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

a study on Parkinson's Disease

Summary

Eligibility
for people ages 50-85 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Parkinson's Disease, Parkinson Disease, Prasinezumab

Eligibility

You can join if…

Open to people ages 50-85

  • 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

You CAN'T join if...

  • 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

  • UCSF Weill Institute for Neurosciences accepting new patients
    San Francisco California 94158 United States
  • Neurology Center of North Orange County accepting new patients
    Fullerton California 92835 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT07174310
Phase
Phase 3 Parkinson's Disease Research Study
Study Type
Interventional
Participants
Expecting 900 study participants
Last Updated
Contact us about this trial