drugset / Trial / NCT02733614
Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD
Phase 2
Terminated
33 enrolled
Azevan Pharmaceuticals
U.S. Army Medical Research and Development Command · collabUnited States Department of Defense · collabWeill Medical College of Cornell University · collab
RandomizedCrossoverQuadruple-blindTreatment
Summary
18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.
Timeline
- Start
- 2016-12
- Primary completion
- 2020-10
- Completion
- 2021-03-31
Outcome
Outcome not reported
Stopped (Business): “funding”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SRX246 | Small molecule | 160 mg | Oral |