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

NCT07670702 · tracked via the Priya Life Science USA tracker

Sponsor

Transcend Therapeutics

Phase

Phase 3

Started

2026-06-22

Last updated

2026-09-04

Condition(s) studied

Post Traumatic Stress Disorder

Investigational drug(s) / intervention(s)

TSND-201

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

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

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.

Primary outcome measure(s)

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.

Trial sites (17)

Facility	City	Region
Preferred Research Partners	Little Rock	Arkansas
CalNeuro Research Group	Los Angeles	California
Catalina Research Institute	Montclair	California
Starlight Clinical Research	Evergreen	Colorado
Clinical Neuroscience Solutions - Jacksonville	Jacksonville	Florida
Segal Trials	Lauderhill	Florida
Accel Clinical Research	Maitland	Florida
CNS Healthcare	Orlando	Florida
Vitalix Clinical	Worcester	Massachusetts
Arch Clinical Trials	Creve Coeur	Missouri
Bio Behavioral Health	Toms River	New Jersey
Insight Clinical Trials	Independence	Ohio
Flourish Research	Plymouth Meeting	Pennsylvania
Austin Clinical Trial Partners	Austin	Texas
Haracec Clinical Research	El Paso	Texas
Cedar Clinical Research	Draper	Utah
Inner Space Research	Orem	Utah

More Transcend Therapeutics trials in the USA

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

Other trials for the same condition

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

Walk With Me (WWM) for Perinatal Grief Recruiting

Exploring Clinical Study Experiences of People With Post Traumatic Stress Disorder Starting soon

Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD) Recruiting

Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07670702 on ClinicalTrials.gov ↗ ← All trials in the USA