A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
Start Date
6/17/2025
Completion Date
3/1/2032
Summary
Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).
Detailed Description
The BRT-DA01-301 study is a Phase 3, multicenter, randomized, sham surgery-controlled, double-blind study involving approximately 102 participants with Parkinson's Disease (PD). Participants will be randomized in a 2:1 ratio to either receive bemdaneprocel or undergo sham surgery. The study includes an immunosuppression regimen and placebo equivalents to maintain blinding. The primary objective is to evaluate the efficacy of bemdaneprocel on motor symptoms in participants with PD. The secondary objective is to evaluate the effects of bemdaneprocel on Motor function, Quality of life, Non-motor symptoms of PD, Disease severity, and Use of PD medications or therapies compared with participants who undergo sham surgery. Participants will be followed for at least 18 months in the double-blind period and up to five years if they receive bemdaneprocel.
Eligibility Criteria
Age Range: 45 years to 75 years
Interventions
bemdaneprocel
Sham surgery
Conditions
Locations
Banner Sun Health Research Institute
Sun City, Arizona 85351
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United States
UCLA NeuroTranslational Research Center
Los Angeles, California 90095
United States
UCI Medical Center - Neurology
Orange, California 92868
United States
Stanford Neuroscience Health Center
Palo Alto, California 94304
United States
University of Colorado Hospital - Neurology Clinic
Aurora, Colorado 80045
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
Mayo Clinic Jacksonville - Neurology
Jacksonville, Florida 32224
United States
University of Miami Health System - Neurology
Miami, Florida 33136
United States
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida 33613
United States
Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital
Chicago, Illinois 60611
United States
Rush University Medical Center - Neurology
Chicago, Illinois 60612
United States
University of Kansas Medical Center
Kansas City, Kansas 66160-8500
United States
University of Louisville Hospital
Louisville, Kentucky 40202
United States
Johns Hopkins Hospital - Neurology
Baltimore, Maryland 21287
United States
Tufts Medical Center - Neurology
Boston, Massachusetts 02111
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Michigan Clinical Research Unit - Neurology
Ann Arbor, Michigan 48109
United States
University of Michigan Clinical Research Unit - Neurology
Ann Arbor, Michigan 48109
United States
Quest Research Institute
Farmington Hills, Michigan 48334
United States
UBMD Neurology
Buffalo, New York 14221
United States
Mount Sinai West - Neurology
New York, New York 10019
United States
New York Presbyterian/Weill Cornell Medical Center
New York, New York 10065
United States
Duke Neurological Disorders Clinic
Durham, North Carolina 27710
United States
University of Toledo Medical Center
Toledo, Ohio 43614
United States
OHSU Neurology Clinic, South Waterfront
Portland, Oregon 97239
United States
Rhode Island Hospital - Neurology
Providence, Rhode Island 02903
United States
Medical University of South Carolina, Movement Disorders Dept.
Charleston, South Carolina 29425
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
UTHealth Houston Neurosciences - Texas Medical Center
Houston, Texas 77030
United States
University of Vermont Medical Center
Burlington, Vermont 05401
United States
Virginia Commonwealth University
Richmond, Virginia 23284
United States
EvergreenHealth - Research Department
Kirkland, Washington 98034
United States
NeuRA (Neuroscience Research Australia)
Randwick, New South Wales 2031
Australia
Gold Coast Hospital & Health Service
Southport, Queensland 4215
Australia
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
Australia
Monash Medical Centre
Clayton, Victoria 3168
Australia
The Alfred Hospital
Melbourne, Victoria 3004
Australia
The Royal Melbourne Hospital
Parkville, Victoria 3050
Australia
The University of British Columbia
Vancouver, British Columbia V6T 1Z3
Canada
University Health Network - Toronto Western Hospital
Toronto, Ontario M5T 2S8
Canada
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec H2X 0C1
Canada