Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD
Status:
Terminated
Trial end date:
2021-03-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Azevan Pharmaceuticals
Collaborators:
U.S. Army Medical Research and Development Command U.S. Army Medical Research and Materiel Command United States Department of Defense Weill Medical College of Cornell University