An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
EMPOWER-2
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
1 other identifier
interventional
300
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2026
CompletedFirst Submitted
Initial submission to the registry
September 17, 2026
CompletedFirst Posted
Study publicly available on registry
September 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
September 23, 2026
September 1, 2026
1.4 years
September 17, 2026
September 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
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.
Up to 12 Weeks
Study Arms (3)
TSND-201, Dose Level 1
EXPERIMENTALTSND-201, Dose Level 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Meets 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.
You may not qualify if:
- Primary diagnosis of any other DSM-5 disorder.
- Body mass index (BMI) \<18kg/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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mountain View Clinical Research
Denver, Colorado, 80209, United States
Bradenton Research Center
Bradenton, Florida, 34205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2026
First Posted
September 23, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
September 23, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share