Ganaxolone in Posttraumatic Stress Disorder (PTSD)

Marinus Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

PTSD

Treatments

Drug: Placebo

Drug: Ganaxolone

Study type

Interventional

Funder types

Other

Industry

Other U.S. Federal agency

Identifiers

NCT01339689

1042-0700

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Veteran or civilian adult outpatients 18-55 years of age, with primary PTSD as defined by Diagnostic and Statistical manual of Mental Disorders-IV (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 participants 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
Participants with recent drug abuse or dependency (excluding nicotine and caffeine)
Participants 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
Participants with pending litigation related to the traumatic event
Participants who are unwilling to withhold grapefruit or grapefruit juice for the duration of the study
Participants receiving psychotherapy without a stable paradigm for at least 3 months
Non-English speaking participants.