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NCT01339689 · ClinicalTrials.gov registry record · Phase 2
Ganaxolone in Posttraumatic Stress Disorder (PTSD)
A Phase 2 study, sponsored by Marinus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
NCT01339689 is a Phase 2 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 112 participants.
The verdict
NCT01339689, a Phase 2 study, has completed, sponsored by Marinus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01339689
The ClinicalTrials.gov registry entry for NCT01339689 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Marinus Pharmaceuticals, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01339689 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01339689 about?
NCT01339689 is a clinical study titled "Ganaxolone in Posttraumatic Stress Disorder (PTSD)". 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 we...
What is the current status of trial NCT01339689?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2011-04. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01339689?
The interventions under investigation include: Placebo (DRUG), Ganaxolone (DRUG).
Who is sponsoring clinical trial NCT01339689?
This trial is sponsored by Marinus Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
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