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

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

Status

Enrolling by invitation

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07670702

Acronym

EMPOWER-EXT

Enrollment

300

Registered

2026-06-26

Start date

2026-06-22

Completion date

2029-01-01

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD, EMPOWER-EXT, Transcend Therapeutics, TSND-201, Neuroplastogen

Brief summary

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.

Interventions

DRUGTSND-201

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026