An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-2)

November 1, 2026 updated by: Transcend Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80209
        • Recruiting
        • Mountain View Clinical Research
        • Contact:
    • Florida
      • Bradenton, Florida, United States, 34205
      • Orlando, Florida, United States, 32801
      • Tampa, Florida, United States, 33613
      • Tampa, Florida, United States, 33634
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • CenExel Atlanta
        • Contact:
          • Elyssa Barron, MD
          • Phone Number: 404-881-5800
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • CenExel Marlton
        • Contact:
          • Lisa Wilkins
          • Phone Number: 888-437-4104
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Bio Behavioral Health
        • Contact:
    • Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets 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) <18kg/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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo

Placebo capsules, given orally, once a week for four consecutive weeks
Experimental: TSND-201, Dose Level 1
Drug: TSND-201

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

Other Names:
  • methylone
Experimental: TSND-201, Dose Level 2
Drug: TSND-201

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

Other Names:
  • methylone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
Time Frame: Up to 12 Weeks

CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
Up to 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transcend Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

September 17, 2026

First Submitted That Met QC Criteria

September 17, 2026

First Posted (Actual)

September 23, 2026

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

November 1, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSND201-PTSD-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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