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Enrolling by Invitation

NCT Number: NCT07670702

An Evaluation of the Long-Term Safety and Efficacy of TSND-201 for the Treatment of PTSD

This study is evaluating the long-term safety and efficacy of TSND-201 in adults with PTSD. Participants that have completed a double-blind clinical trial with TNSD-201 for PTSD will be invited to participate in this open-label extension trial.

Each participant will be able to receive up to three Treatment Courses over the duration of the study (up to 48 weeks). Each Treatment Course includes 4 dosing sessions, spaced one week apart.

Enrolling by Invitation

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CNS Healthcare

Orlando, Florida, 32801, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completion of a double-blind Transcend-sponsored clinical trial with TSND-201 (e.g., TSND201-PTSD-301) and considered in good standing with the study site.
  • Proficient in communication (verbal and reading) to complete interviews and written questionnaires.
  • Agree to not participate in any other interventional clinical trials for the duration of this study.

Exclusion criteria

  • Experienced an intolerable side effect following dosing with TSND-201 in the prior study.
  • Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
  • Change or development of any physical or psychological finding that would make participant unsuitable for study.

Treatment and study plan

TSND-201

Drug

TSND-201 capsules, given orally; where a course of treatment includes dosing with TSND-201 once a week for four consecutive weeks

Primary outcomes

  1. Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score

    Time frame: Up to 48 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.

Sponsors and collaborators

Lead sponsor

Transcend Therapeutics

Industry

Registry information

Official study title

A Phase 3 Open-Label Extension Study to Assess the Long-term Safety and Efficacy of TSND-201 for the Treatment of PTSD

Acronym: EMPOWER-EXT

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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