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

Study acronym: exPDite-2
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Study sites: 42 to 43v14
  2. Minor Study sites: 40 to 42v13
  3. Minor Study sites: 39 to 40v12
  4. Minor Study sites: 37 to 39v11
  5. Minor Trial sites expanded: 33 → 37 locationsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Study sites: 29 to 33v9
  2. Minor Study sites: 18 to 29v8
  3. Minor Study sites: 14 to 18v7
  4. Minor Study sites: 10 to 14
    • Eligibility criteria expanded, about 104 words
    v6
  5. Minor Study sites: 7 to 10v5
  6. Minor Study sites revised (7)v4
  7. Minor Start date changed from estimate of May 2025 to Jun 17, 2025
    • Site details revised at 1 of 7 sites
    v3
  8. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 7 of 7 sites
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06944522
Lead Sponsor BlueRock Therapeutics
Collaborators: Bayer
Conditions
(from sponsor)
Parkinsons Disease (PD)
Related terms Parkinson Disease
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov