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

Transcend Therapeutics

Status and phase

Invitation-only

Phase 3

Conditions

Post Traumatic Stress Disorder

Treatments

Drug: TSND-201

Study type

Interventional

Funder types

Industry

Identifiers

NCT07670702

TSND201-PTSD-303

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Volunteers

No 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.