Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD

Azevan Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: PTSD

Treatments: Drug: SRX246; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT02733614

AVN010

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medically stable, current diagnosis of PTSD

Exclusion criteria

• Medically unstable

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

33 participants in 2 patient groups, including a placebo group

SRX246

Experimental group

Description:

SRX246 160 mg BID, oral administration, capsules, daily for 8 weeks

Treatment:

Drug: SRX246

Placebo

Placebo Comparator group

Description:

oral administration, capsules, daily for 8 weeks

Treatment:

Drug: Placebo