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An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)
NCT07456696 · Transcend Therapeutics
In plain English
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Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
About this study
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.
Eligibility criteria
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
Enrollment target: 300 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-04-02
Estimated completion: 2027-12
Last updated: 2026-05-20
Interventions
Drug: TSND-201Drug: Placebo
Primary outcomes
- • Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score (Up to 12 weeks)
Sponsor
Transcend Therapeutics · industry
Contacts & investigators
ContactStudy Director · contact · amanda@transcendtherapeutics.com · 650-769-6472
All locations (26)
Preferred Research PartnersRecruiting
Little Rock, Arkansas, United States
Kadima NeuropsychiatryRecruiting
La Jolla, California, United States
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Los Angeles, California, United States
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Montclair, California, United States
Excell ResearchRecruiting
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CNS HealthcareRecruiting
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Headlands Research - PharmasiteRecruiting
Pikesville, Maryland, United States
Vitalix ClinicalRecruiting
Worcester, Massachusetts, United States
Midwest Research GRoupRecruiting
Saint Charles, Missouri, United States
Center for Emotional Fitness/ Lumina Clinical Research CenterRecruiting
Cherry Hill, New Jersey, United States
Global Medical InstitutesRecruiting
Princeton, New Jersey, United States
Bio Behavioral HealthRecruiting
Toms River, New Jersey, United States
Medical Research NetworkRecruiting
New York, New York, United States
Insight Clinical TrialsRecruiting
Independence, Ohio, United States
Flourish ResearchRecruiting
Plymouth Meeting, Pennsylvania, United States
Suburban Research AssociatesRecruiting
West Chester, Pennsylvania, United States
Austin Clinical Trial PartnersRecruiting
Austin, Texas, United States
Haracec Clinical ResearchRecruiting
El Paso, Texas, United States
Inner Space ResearchRecruiting
Orem, Utah, United States
Seattle Neuropsychiatric Treatment Center (NTC)Recruiting
Seattle, Washington, United States