Ganaxolone in Posttraumatic Stress Disorder (PTSD)
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled,
15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress
Disorder (PTSD). Up to 120 subjects will be enrolled and randomized to receive either
ganaxolone or placebo for 6 weeks. After 6 wks of randomized treatment all subjects will
continue for 6 wks on ganaxolone. The aim of the study is to assess the efficacy of
ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment
using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to
evaluate the safety and tolerability of ganaxolone in the PTSD population.
Phase:
Phase 2
Details
Lead Sponsor:
Marinus Pharmaceuticals
Collaborators:
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium U.S. Army Medical Research and Development Command U.S. Army Medical Research and Materiel Command