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

Purpose

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.

Condition

  • Parkinson's Disease

Eligibility

Eligible Ages
Between 50 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Prasinezumab 		Participants will receive Prasinezumab as an IV infusion in the double blind treatment period. Upon completion, eligible participants will enter into the Open Label Extension (OLE) phase.
  • Drug: Prasinezumab
    Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
Experimental
Placebo 		Participants will receive placebo as an IV Infusion.
  • Drug: Placebo
    Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: BN44715 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com