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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

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 5351247, California 5332921 92835

UCSF Weill Institute for Neurosciences
San Francisco 5391959, California 5332921 94158

Rocky Mountain Movement Disorders
Englewood 5421250, Colorado 5417618 80113

Institute for Neurodegenerative Disorders
New Haven 4839366, Connecticut 4831725 06510

JEM Research LLC
Atlantis 4146372, Florida 4155751 33462

Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton 4148411, Florida 4155751 33486

K2 - Villages
Lady Lake 4161118, Florida 4155751 32159

K2 Medical Research-Maitland
Maitland 4163220, Florida 4155751 32751

Charter Research - Winter Park/Orlando
Orlando 4167147, Florida 4155751 32803

Hawaii Pacific Neuroscience
Honolulu 5856195, Hawaii 5855797 96817

Quest Research Institute
Farmington Hills 4992523, Michigan 5001836 48334

Dent Neurological Institute
Amherst 5107129, New York 5128638 14226

NeuroCare Center
Canton 5149222, Ohio 5165418 44718

The Movement Disorder Clinic of Oklahoma
Tulsa 4553433, Oklahoma 4544379 74136

Central Texas Neurology Consultants
Round Rock 4724129, Texas 4736286 78681

West Virginia University
Morgantown 4815352, West Virginia 4826850 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.