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

ConditionParkinsons Disease (PD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age45-75
SponsorBlueRock Therapeutics

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 supranuclear palsy, corticobasal degeneration, or Lewy body dementia

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

History of gene therapy or cell therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • bemdaneprocel

    Biological/Vaccine

    Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells

  • Sham surgery

    Procedure/Surgery

    Sham surgery will be performed on Day 0

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Change from baseline in PD diary measure of OFF-time, adjusted for a 16-hour waking day

Time frame
From baseline to Week 78
2

Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in the off-medication state. Part III score can range from 0 to 132, with lower scores being better.

Time frame
From baseline to Week 78
3

Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score. Part II score can range from 0 to 52, with lower scores being better.

Time frame
From baseline to Week 78
4

Change from baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index. Summary index score can range from 0 to 100, with lower scores being better.

Time frame
From baseline to Week 78

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BlueRock Therapeutics

Lead sponsor

Bayer

Collaborator

Source ClinicalTrials.gov
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