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

Neurology Center of North Orange County
Fullerton, California 92835

Keck School of Medicine of USC
Los Angeles, California 900033

Parkinson?s Research Centers of America ? Palo Alto
Palo Alto, California 94301

Profound Research LLC at The Neurology Center of Southern California
Pasadena, California 91105

UCSF Weill Institute for Neurosciences
San Francisco, California 94158

Rocky Mountain Movement Disorders
Englewood, Colorado 80113

Institute for Neurodegenerative Disorders
New Haven, Connecticut 06510

JEM Research LLC
Atlantis, Florida 33462

Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida 33486

K2 - Villages
Lady Lake, Florida 32159

K2 Medical Research-Maitland
Maitland, Florida 32751

Charter Research - Winter Park/Orlando
Orlando, Florida 32803

Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817

University of Kansas Medical Center
Kansas City, Kansas 66160

Massachusetts General Hospital
Boston, Massachusetts 02114

Quest Research Institute
Farmington Hills, Michigan 48334

Washington Uni School of Medicine
St Louis, Missouri 63110

Renown Health
Reno, Nevada 89502

Dent Neurological Institute
Amherst, New York 14226

Parkinson's Research Centers of America - Long Island
Commack, New York 11725

Weill Cornell Medical College
New York, New York 10021

NeuroCare Center
Canton, Ohio 44718

Cleveland Clinic
Cleveland, Ohio 44195

The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma 74136

Veracity Neuroscience
Memphis, Tennessee 38157

Texas Neurology PA
Dallas, Texas 75206

Central Texas Neurology Consultants
Round Rock, Texas 78681

University of Virginia Health System
Charlottesville, Virginia 22903

West Virginia University
Morgantown, West Virginia 26506

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