NCT01339689

Ganaxolone in Posttraumatic Stress Disorder (PTSD)

A Proof-of-Concept, Double-blind, Randomized, Placebo-controlled Study of Ganaxolone in Posttraumatic Stress Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Marinus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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 participants will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 weeks of randomized treatment all participants will continue for 6 weeks 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.

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	Ganaxolone	200-600 mg bid, capsules, up to 12 weeks
DRUG	Placebo	capsules, bid, up to 12 weeks

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-01-01
• Completion: 2014-03-01
• First posted: 2011-04-21
• Last updated: 2022-12-29
• Results posted: 2022-12-29

Locations

8 sites across 1 country: United States