drugset / Trial / NCT02055638

Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder

NCT02055638 ↗

Phase 1/2 Completed 97 enrolled Azevan Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is designed to explore the safety and tolerability, and to compare the activity of SRX246 against placebo, in adults with Intermittent Explosive Disorder (IED). Adult Male and Female subjects with a current diagnosis of IED will be enrolled. After a two-week baseline lead-in phase, study subjects who continue to meet enrollment criteria will be randomized to either SRX246 or Placebo treatment groups. Study subjects will be examined and asked to answer questionnaires at weekly scheduled visits throughout the trial. The study results will be determined based on any changes observed over the study period.

Timeline

Start
2014-05
Primary completion
2016-05
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject SRX246 Small molecule 160 mg —