An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
Transcend Therapeutics
300 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Meets the DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months.
- Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy.
- Proficient in communication (verbal and reading) to complete interviews and written questionnaires.
- Free from any other clinically significant illness or disease.
Exclusion Criteria5
- Primary diagnosis of any other DSM-5 disorder.
- Body mass index (BMI) \<18 kg/m2 or ≥40 kg/m2.
- Unable to refrain from nicotine use for at least 8 hours.
- Use of prohibited concomitant medications or therapies.
- Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions.
Interventions
TSND-201 capsules, given orally, once a week for four consecutive weeks
Placebo capsules, given orally, once a week for four consecutive weeks
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07456696