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Ganaxolone in Posttraumatic Stress Disorder (PTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01339689
Recruitment Status : Completed
First Posted : April 21, 2011
Last Update Posted : October 21, 2015
Sponsor:
Collaborators:
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Marinus Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
PTSD Drug: Ganaxolone Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Proof-of-Concept, Double-blind, Randomized, Placebo-controlled Study of Ganaxolone in Posttraumatic Stress Disorder
Study Start Date : April 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ganaxolone
active
Drug: Ganaxolone
200-600 mg bid, capsules, up to 12 weeks
Other Name: GNX

Placebo Comparator: Placebo
non-active
Drug: Placebo
capsules, bid, up to 12 weeks
Other Name: PBO




Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale (CAPS) scores. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. CGI-I scores [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339689


Locations
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United States, California
VA San Diego Healthcare System/ University of California, San Diego
San Diego, California, United States, 92093
United States, District of Columbia
Washington DC VA Medical Center/ Uniformed Services University of the Health Services
Washington DC, District of Columbia, United States, 20422
United States, Massachusetts
VA Boston Healthcare Services/ Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02130
United States, New Hampshire
Manchester VA Medical Center/ Dartmouth College
Manchester, New Hampshire, United States, 03104
United States, North Carolina
Durham VA Medical Center /Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati VA Medical Center/ University of Cincinnati
Cincinnati, Ohio, United States, 45220
United States, South Carolina
Charleston VA Medica Center/ Medical University of South Carolina
Charleston, South Carolina, United States, 29401
United States, Vermont
White River Junction VA Medical Center/ Dartmouth College
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
Marinus Pharmaceuticals
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Development Command
Investigators
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Principal Investigator: Christine E Marx, MD, MA Duke University Medical Center and Durham VA Medical Center
Principal Investigator: Ann Rasmusson, MD Boston University School of Medicine Research Affiliate, National Center for PTSD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marinus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01339689    
Other Study ID Numbers: 1042-0700
First Posted: April 21, 2011    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015
Keywords provided by Marinus Pharmaceuticals:
PTSD
Posttraumatic Stress Disorder
pharmacotherapy
ganaxolone
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Pregnanolone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs