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Tests treatment safety and results for Parkinsons Disease (PD)
Official title A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
ClinicalTrials.gov ID: NCT06944522
What this study is testing
What is bemdaneprocel?
bemdaneprocel is an investigational medicine, being studied as a potential treatment for parkinsons disease (pd).
Also referred to as MSK-DA01, BRT-DA01.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- Diagnosis of clinically established PD as defined by the International Parkinson and Movement Disorders Society
- Individual of any sex ≥45 to ≤75 years of age at informed consent
- Robust and clear response to DA therapy as defined by MDS-UPDRS Part III
- ≥4 and \<12 years from time of PD diagnosis at informed consent
- Must demonstrate responsiveness to levodopa therapy
You likely can't join if
- PD presenting with recurrent falls
- Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease...
- Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness that may interfere with study...
- History of gene therapy or cell therapy
- Prior treatment with intrajejunal or subcutaneous infusion therapies for PD
- Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal...
See the full eligibility criteria
- Diagnosis of clinically established PD as defined by the International Parkinson and Movement Disorders Society
- Individual of any sex ≥45 to ≤75 years of age at informed consent
- Robust and clear response to DA therapy as defined by MDS-UPDRS Part III
- ≥4 and \<12 years from time of PD diagnosis at informed consent
- Must demonstrate responsiveness to levodopa therapy
- Receiving medical therapy for the treatment of PD symptoms
- ≥2.5 hours of daily OFF-time
- Vaccinated per current national guidelines or local practice for patients with altered immunocompetence
- PD presenting with recurrent falls
- 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...
- 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...
- History of gene therapy or cell therapy
- Prior treatment with intrajejunal or subcutaneous infusion therapies for PD
- Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery
- Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs, or anything that prevents use of PET or MRI
- Any active infection (including but not limited to HIV, HCV, HBV, CMV, syphilis, or tuberculosis) or condition that, in the opinion of the investigator could put the participant at significant risk from...
- Current or previously active malignant disease within the past 5 years
- Chronic immunosuppressive therapy
- Receipt of another investigational therapy within 5 half-lives of the active treatment
- Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Sun City, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Farmington Hills, Michigan, United States
- Buffalo, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sun City, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.