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Ganaxolone in Posttraumatic Stress Disorder (PTSD)

NCT01339689 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2022-12-29

Study results available
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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

Interventions

DRUG

Ganaxolone

200-600 mg bid, capsules, up to 12 weeks

DRUG

Placebo

capsules, bid, up to 12 weeks

Sponsors & Collaborators

  • INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

    collaborator OTHER

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Marinus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Christine E Marx, MD, MA · Duke University Medical Center and Durham VA Medical Center

  • Ann Rasmusson, MD · Boston University School of Medicine Research Affiliate, National Center for PTSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-01-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01339689 on ClinicalTrials.gov