Bemdaneprocel for Parkinson's Disease

(exPDite-2 Trial)

Recruiting at 6 trial locations

Overseen By Patient Engagement

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: BlueRock Therapeutics

Must be taking: Levodopa

Must not be taking: Immunosuppressants

Disqualifiers: Epilepsy, Stroke, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, since participants must be receiving medical therapy for Parkinson's symptoms, it seems likely you can continue your current treatment.

Are You a Good Fit for This Trial?

Adults with Parkinson's Disease are eligible for this trial. Participants must meet certain health criteria, which will be determined by the study team. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I was diagnosed with Parkinson's disease between 4 and 12 years ago.

My condition improves with levodopa treatment.

I am currently on medication for Parkinson's disease symptoms.

Exclusion Criteria

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

Receipt of another investigational therapy

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bemdaneprocel or undergo sham surgery on Day 0, followed by an immunosuppression regimen

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Bemdaneprocel
• Sham surgery

Trial Overview The trial is testing bemdaneprocel against a sham (fake) surgery to see if it's effective and safe in treating Parkinson's Disease. It's a Phase 3 study where participants are randomly assigned to either the real treatment or placebo, without knowing which they receive.

How Is the Trial Designed?

Group I: Group A Active Control 1 Intervention

Bemdaneprocel will be administered on Day 0

Group II: Group B Placebo Group 1 Intervention

Sham surgery will be performed on Day 0

Who Is Running the Clinical Trial?

BlueRock Therapeutics

Lead Sponsor

Trials

4

Recruited

270+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD