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

NCT07456696 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Post Traumatic Stress Disorder

Interventions

DRUG

TSND-201

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Transcend Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-02
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07456696 on ClinicalTrials.gov