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An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)
Sponsor: Transcend Therapeutics
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.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-03
Completion Date
2027-12
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
TSND-201
TSND-201 capsules, given orally, once a week for four consecutive weeks
Placebo
Placebo capsules, given orally, once a week for four consecutive weeks
Locations (3)
Preferred Research Partners
Little Rock, Arkansas, United States
CNS Healthcare
Jacksonville, Florida, United States
CNS Healthcare
Orlando, Florida, United States