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An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)

Study acronym: EMPOWER-1
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 32 → 37 locations Eligibility criteria expanded, about 9 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 9 words
  2. Trial sites expanded: 26 → 32 locationsv6
  3. Trial sites expanded: 19 → 26 locationsv5
  4. Re-verified, no change to tracked fieldsv4
  5. Trial sites expanded: 3 → 19 locations Start date changed from estimate of Mar 2026 to Apr 2, 2026v3 Show 1 more changeShow less
    • Start date changed from estimate of Mar 2026 to Apr 2, 2026
  6. Re-verified, no change to tracked fieldsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.
Trial Details
NCT Number NCT07456696
Lead Sponsor Transcend Therapeutics
Conditions Post Traumatic Stress Disorder
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov