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Recruiting NCT07456696

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

Phase III Interventional Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TSND-201, Placebo.
Who it may be relevant to
Registry conditions: Post Traumatic Stress Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD

Overview

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.

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

Primary outcome measures

  • Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score [Time frame: Up to 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 32 centers
  • Del Sol Research — Tucson
  • Preferred Research Partners — Little Rock
  • Kadima Neuropsychiatry — La Jolla
  • CalNeuro Research Group — Los Angeles
  • Catalina Research Institute — Montclair
  • Excell Research — Oceanside
  • ATP Clinical Research — Orange
  • Inland Psychiatric Medical Group — San Juan Capistrano
  • … and 24 more centers

Identifiers

NCT: NCT07456696 · TSND201-PTSD-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗