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

Purpose

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.

Condition

  • Post Traumatic Stress Disorder

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TSND-201, Dose Level 1
  • Drug: TSND-201
    TSND-201 capsules, given orally, once a week for four consecutive weeks
    Other names:
    • methylone
Experimental
TSND-201, Dose Level 2
  • Drug: TSND-201
    TSND-201 capsules, given orally, once a week for four consecutive weeks
    Other names:
    • methylone
Placebo Comparator
Placebo
  • Drug: Placebo
    Placebo capsules, given orally, once a week for four consecutive weeks

Recruiting Locations

Preferred Research Partners
Little Rock, Arkansas 72211
Contact:
Study Coordinator

CNS Healthcare
Jacksonville, Florida 32256
Contact:
Study Coordinator
904-281-5757

CNS Healthcare
Orlando, Florida 32801
Contact:
Ashley Westerfeld
awesterfeld@cnshealthcare.com

More Details

Status
Recruiting
Sponsor
Transcend Therapeutics

Study Contact

Study Director
650-769-6472
empower-1@transcendtherapeutics.com