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An Evaluation of the Long-Term Safety and Efficacy of TSND-201 for the Treatment of PTSD

Study acronym: EMPOWER-EXT
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 1 → 17 locations Start date changed from estimate of Jun 2026 to Jun 22, 2026v2 Show 1 more changeShow less
    • Start date changed from estimate of Jun 2026 to Jun 22, 2026
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is evaluating the long-term safety and efficacy of TSND-201 in adults with PTSD. Participants that have completed a double-blind clinical trial with TNSD-201 for PTSD will be invited to participate in this open-label extension trial. Each participant will be able to receive up to three Treatment Courses over the duration of the study (up to 48 weeks). Each Treatment Course includes 4 dosing sessions, spaced one week apart.
Trial Details
NCT Number NCT07670702
Lead Sponsor Transcend Therapeutics
Conditions Post Traumatic Stress Disorder
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov