RecruitingPhase 3NCT07456696

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


Sponsor

Transcend Therapeutics

Enrollment

300 participants

Start Date

Apr 2, 2026

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called EMPOWER-1) tests the safety and effectiveness of a new drug called TSND-201 for adults with post-traumatic stress disorder (PTSD)—a condition that develops after experiencing a traumatic event and involves symptoms like flashbacks, nightmares, severe anxiety, and emotional numbness. Participants must have had PTSD symptoms for at least 6 months and have already tried at least one other treatment. **You may be eligible if...** - You have a current diagnosis of PTSD with symptoms lasting at least 6 months - You have previously tried at least one medication for PTSD or completed trauma-focused therapy - You are otherwise in good general health - You can complete interviews and written questionnaires **You may NOT be eligible if...** - You have a primary diagnosis of another psychiatric disorder - Your BMI is below 18 or 40 or above (very underweight or very obese) - You are unable to avoid nicotine use for at least 8 hours before assessments - You have a significant cardiovascular or brain-related health history (including uncontrolled high blood pressure) - You are taking certain prohibited medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTSND-201

TSND-201 capsules, given orally, once a week for four consecutive weeks

DRUGPlacebo

Placebo capsules, given orally, once a week for four consecutive weeks


Locations(19)

Preferred Research Partners

Little Rock, Arkansas, United States

CalNeuro Research Group

Los Angeles, California, United States

Catalina Research Institute

Montclair, California, United States

Inland Psychiatric Medical Group

San Juan Capistrano, California, United States

Starlight Clinical Research

Evergreen, Colorado, United States

CNS Healthcare

Jacksonville, Florida, United States

Segal Trials

Lauderhill, Florida, United States

Accel Clinical Research

Maitland, Florida, United States

CNS Healthcare

Orlando, Florida, United States

Uptown Research Institute

Chicago, Illinois, United States

Vitalix Clinical

Worcester, Massachusetts, United States

Midwest Research GRoup

Saint Charles, Missouri, United States

Global Medical Institutes

Princeton, New Jersey, United States

Bio Behavioral Health

Toms River, New Jersey, United States

Insight Clinical Trials

Independence, Ohio, United States

Suburban Research Associates

West Chester, Pennsylvania, United States

Austin Clinical Trial Partners

Austin, Texas, United States

Haracec Clinical Research

El Paso, Texas, United States

Inner Space Research

Orem, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT07456696


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