Trial intelligence / Profile preview

SRX246 in PTSD

NCT02733614Phase 2

Key facts

Status: Terminated
Start: Dec 2016
Primary completion: Oct 2020
Countries: 1
Sponsor: Azevan Pharmaceuticals
Modality: Small Molecules

Drugs: SRX246
Conditions: post-traumatic stress disorder (PTSD)

Overview

Phase 2, randomised, double-blind trial of SRX246 in post-traumatic stress disorder (PTSD) (2 arms), sponsored by Azevan Pharmaceuticals. Primary endpoint: Assessment of overall clinical improvement at 18 weeks. Started Dec 2016; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

SRX246 -> Placebo
SRX246 160 mg BID for 8 weeks, then washout, then Placebo for 8 weeks
Placebo -> SRX246
Placebo for 8 weeks, then washout, then SRX246 160 mg BID for 8 weeks

Who it enrols

Adult veterans and civilians with a primary diagnosis of PTSD who are medically stable.

Endpoints

Primary

Assessment of overall clinical improvement18 weeks

Secondary

Number of participants with treatment-related adverse events18 weeks
Reduction in depressive symptoms18 weeks
Reduction in anger and aggression18 weeks
Reduction in irritability18 weeks
Improvement in overall functioning18 weeks
Improvement in quality of life18 weeks
Improvement in sleep quality18 weeks

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