drugset / Trial / NCT07456696

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

NCT07456696

Phase 3 Recruiting 300 enrolled Transcend Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2026-04-02
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylone Other / unclassified Oral