A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease

Part of paid clinical trials in Sun City, Arizona.

Sponsor
BlueRock Therapeutics
Study ID
NCT06944522
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Parkinsons Disease (PD)

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • bemdaneprocel — BIOLOGICAL
    Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells
  • Sham surgery — PROCEDURE
    Sham surgery will be performed on Day 0

Study Details

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).

Key Dates

Start date
Jun 17, 2025
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2032

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A
    Bemdaneprocel will be administered on Day 0
  • Sham Comparator: Group B
    Sham surgery will be performed on Day 0

Primary Outcome Measure

Change from baseline in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day [ Time Frame: From baseline to Week 78 ]

Central Contacts

Locations (31)

FacilityCityStateZIPSite coordinators
Banner Sun Health Research InstituteSun CityArizona85351
Patient Engagement
[email protected]
1-877-380-3967
University of Arkansas for Medical SciencesLittle RockArkansas72205
Patient Engagement
[email protected]
1-877-380-3967
UCLA NeuroTranslational Research CenterLos AngelesCalifornia90095
Patient Engagement
[email protected]
1-877-380-3967
UCI Medical Center - NeurologyOrangeCalifornia92868
Patient Engagement
[email protected]
1-877-380-3967
University of Colorado Hospital - Neurology ClinicAuroraColorado80045
Patient Engagement
[email protected]
1-877-380-3967
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Patient Engagement
[email protected]
1-877-380-3967
University of Miami Health System - NeurologyMiamiFlorida33136
Patient Engagement
[email protected]
1-877-380-3967
USF Parkinson's Disease and Movement Disorders CenterTampaFlorida33613
Patient Engagement
[email protected]
1-877-380-3967
Parkinson's Disease and Movement Disorders Center at Northwestern Memorial HospitalChicagoIllinois60611
Patient Engagement
[email protected]
1-877-380-3967
Rush University Medical Center - NeurologyChicagoIllinois60612
Patient Engagement
[email protected]
1-877-380-3967
University of Kansas Medical CenterKansas CityKansas66160-8500
Patient Engagement
[email protected]
1-877-380-3967
University of Louisville HospitalLouisvilleKentucky40202
Patient Engagement
[email protected]
1-877-380-3967
Johns Hopkins Hospital - NeurologyBaltimoreMaryland21287
Patient Engagement
[email protected]
1-877-380-3967
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Patient Engagement
[email protected]
1-877-380-3967
Tufts Medical Center - NeurologyBostonMassachusetts02111
Patient Engagement
[email protected]
1-877-380-3967
Michigan Clinical Research Unit - NeurologyAnn ArborMichigan48109
Patient Engagement
[email protected]
1-877-380-3967
University of Michigan Clinical Research Unit - NeurologyAnn ArborMichigan48109
Patient Engagement
[email protected]
1-877-380-3967
Quest Research InstituteFarmington HillsMichigan48334
Patient Engagement
[email protected]
1-877-380-3967
UBMD NeurologyBuffaloNew York14221
Patient Engagement
[email protected]
1-877-380-3967
Mount Sinai West - NeurologyNew YorkNew York10019
Patient Engagement
[email protected]
1-877-380-3967
New York Presbyterian/Weill Cornell Medical CenterNew YorkNew York10065
Patient Engagement
[email protected]
1-877-380-3967
Duke Neurological Disorders ClinicDurhamNorth Carolina27710
Patient Engagement
[email protected]
1-877-380-3967
University of Toledo Medical CenterToledoOhio43614
Patient Engagement
[email protected]
1-877-380-3967
OHSU Neurology Clinic, South WaterfrontPortlandOregon97239
Patient Engagement
[email protected]
1-877-380-3967
Rhode Island Hospital - NeurologyProvidenceRhode Island02903
Patient Engagement
[email protected]
1-877-380-3967
Medical University of South Carolina, Movement Disorders Dept.CharlestonSouth Carolina29425
Patient Engagement
[email protected]
1-877-380-3967
Vanderbilt University Medical CenterNashvilleTennessee37232
Patient Engagement
[email protected]
1-877-380-3967
UTHealth Houston Neurosciences - Texas Medical CenterHoustonTexas77030
Patient Engagement
[email protected]
1-877-380-3967
University of Vermont Medical CenterBurlingtonVermont05401
Patient Engagement
[email protected]
1-877-380-3967
Virginia Commonwealth UniversityRichmondVirginia23284
Patient Engagement
[email protected]
1-877-380-3967
EvergreenHealth - Research DepartmentKirklandWashington98034
Patient Engagement
[email protected]
1-877-380-3967

Find similar trials in Sun City, AZ

By research site
Banner Sun Health Research Institute· Sun City, AZUniversity of Arkansas for Medical Sciences· Little Rock, ARUCLA NeuroTranslational Research Center· Los Angeles, CAUCI Medical Center - Neurology· Orange, CAUniversity of Colorado Hospital - Neurology Clinic· Aurora, COMedStar Georgetown University Hospital· Washington D.C., DC

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