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NCT06944522 | NOT YET RECRUITING | Parkinsons Disease (PD)

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

BlueRock Therapeutics

Brief 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).

Condition or disease

Parkinsons Disease (PD)

Intervention/treatment

bemdaneprocel

Sham surgery

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 102 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : exPDite-2: A Phase 3 Study to Assess the Efficacy and Safety of Midbrain Dopaminergic Neuronal Cell Therapy (Bemdaneprocel) for Participants With Parkinson's Disease
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2027-03
Estimated Study Completion Date : 2032-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Individual of any sex ≥45 to ≤75 years of age at informed consent
  • 2. Diagnosis of clinically established PD
  • 3. ≥4 and \<12 years from time of PD diagnosis at informed consent
  • 4. Must demonstrate responsiveness to levodopa therapy
  • 5. Receiving medical therapy for the treatment of PD symptoms
  • 6. ≥2.5 hours of daily OFF-time
Exclusion Criteria
  • 1. PD presenting with recurrent falls
  • 2. Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, or Lewy body dementia
  • 3. Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness that may interfere with study participation, participant's safety, or assessment of endpoints per investigator's judgment
  • 4. History of gene therapy or cell therapy
  • 5. Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery
  • 6. Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs
  • 7. Current or previously active malignant disease within the past 5 years
  • 8. Chronic immunosuppressive therapy
  • 9. Receipt of another investigational therapy
  • 10. Pregnancy or breastfeeding
A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease

Location Details

NCT06944522

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States, 33486

Not yet recruiting

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

Not yet recruiting

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160-8500

Not yet recruiting

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114-2696

Not yet recruiting

United States, Road cancer

Quest Research Institute

Farmington Hills, Road cancer, United States, 48334

Not yet recruiting

United States, New York

New York Presbyterian/Weill Cornell Medical Center

New York, New York, United States, 10065

Not yet recruiting

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903