This trial is active, not recruiting.

Condition ptsd
Treatments ganaxolone, placebo
Phase phase 2
Sponsor Marinus Pharmaceuticals
Collaborator INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Start date April 2011
End date January 2014
Trial size 114 participants
Trial identifier NCT01339689, 1042-0700


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
ganaxolone GNX
200-600 mg bid, capsules, up to 12 weeks
(Placebo Comparator)
placebo PBO
capsules, bid, up to 12 weeks

Primary Outcomes

Clinician-Administered PTSD Scale (CAPS) scores.
time frame: 6 weeks

Secondary Outcomes

CGI-I scores
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title A Proof-of-Concept, Double-blind, Randomized, Placebo-controlled Study of Ganaxolone in Posttraumatic Stress Disorder
Principal investigator Christine E Marx, MD, MA
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Marinus Pharmaceuticals.