Ganaxolone in Posttraumatic Stress Disorder (PTSD)

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Ganaxolone; Pregnanolone

Criteria

Key Inclusion Criteria:

• Veteran or civilian adult outpatients 18-55 years of age, with primary PTSD as defined by DSM-IV for at least 6 months

• Must be in general good health-confirmed by medical history, physical examination, and screening laboratory results

• Negative urine drug screen for drugs of abuse

• Negative urine pregnancy test for females of childbearing potential

• Sexually active subjects are required to use a medically acceptable form of birth control

Key Exclusion Criteria

• Clinically unstable medical disease; progressive CNS disorder/disease; history of seizures (except childhood febrile seizure); moderate or severe traumatic brain injury (TBI)

• Females who are pregnant or currently breast feeding

• Current or past psychotic disorder, bipolar Type I disorder, or dementia

• Subjects with recent drug abuse or dependency (excluding nicotine and caffeine)

• Subjects unwilling to comply with the required alcohol prohibition during the trial

• Current suicidal or homicidal ideation necessitating intervention, and those with a history of suicide attempt in the past 10 years

• Subjects with pending litigation related to the traumatic event

• Subjects who are unwilling to withhold grapefruit or grapefruit juice for the duration of the study

• Subjects receiving psychotherapy without a stable paradigm for at least 3 months

• Non-English speaking subjects