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

A

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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