An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- Transcend Therapeutics
- Study ID
- NCT07456696
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- TSND-201 — DRUGTSND-201 capsules, given orally, once a week for four consecutive weeks
- Placebo — DRUGPlacebo capsules, given orally, once a week for four consecutive weeks
Study Details
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.
Key Dates
- Start date
- Apr 2, 2026
- Status verified
- May 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 300 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: TSND-201, Dose Level 1
- Experimental: TSND-201, Dose Level 2
- Placebo Comparator: Placebo
Primary Outcome Measure
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score [ Time Frame: Up to 12 weeks ]
Central Contacts
- Study Director650-769-6472
Locations (26)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Preferred Research Partners | Little Rock | Arkansas | 72211 | Study Coordinator 501-553-9987 |
| Kadima Neuropsychiatry | La Jolla | California | 92037 | David Feifel, MD, PhD 858-412-4130 |
| CalNeuro Research Group | Los Angeles | California | 90025 | |
| Catalina Research Institute | Montclair | California | 91763 | Rachelle Phillips, Site Director |
| Excell Research | Oceanside | California | 92056 | |
| Inland Psychiatric Medical Group | San Juan Capistrano | California | 92675 | |
| Starlight Clinical Research | Evergreen | Colorado | 80439 | |
| CNS Healthcare | Jacksonville | Florida | 32256 | Study Coordinator 904-281-5757 |
| Segal Trials | Lauderhill | Florida | 33319 | Leandro Rueda |
| Accel Clinical Research | Maitland | Florida | 32751 | |
| CNS Healthcare | Orlando | Florida | 32801 | Ashley Westerfeld |
| Uptown Research Institute | Chicago | Illinois | 60640 | Stephen Schneider |
| Headlands Research - Pharmasite | Pikesville | Maryland | 21208 | |
| Vitalix Clinical | Worcester | Massachusetts | 01608 | |
| Midwest Research GRoup | Saint Charles | Missouri | 63304 | |
| Center for Emotional Fitness/ Lumina Clinical Research Center | Cherry Hill | New Jersey | 08002 | |
| Global Medical Institutes | Princeton | New Jersey | 08540 | |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | |
| Medical Research Network | New York | New York | 10128 | |
| Insight Clinical Trials | Independence | Ohio | 44131 | Elisa Poggi 216-526-1843 |
| Flourish Research | Plymouth Meeting | Pennsylvania | 19462 | Landon Este 610-277-8073 |
| Suburban Research Associates | West Chester | Pennsylvania | 19380 | |
| Austin Clinical Trial Partners | Austin | Texas | 78737 | Kara Chilek 512-521-0595 |
| Haracec Clinical Research | El Paso | Texas | 79902 | |
| Inner Space Research | Orem | Utah | 84058 | |
| Seattle Neuropsychiatric Treatment Center (NTC) | Seattle | Washington | 98104 |
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