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

Transcend Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Post Traumatic Stress Disorder

Treatments: Drug: Placebo; Drug: TSND-201

Study type: Interventional

Funder types: Industry

Identifiers

NCT07456696

TSND201-PTSD-301

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets the 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) <18 kg/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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

TSND-201, Dose Level 1

Experimental group

Treatment:

Drug: TSND-201

TSND-201, Dose Level 2

Experimental group

Treatment:

Drug: TSND-201

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo