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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: Completed Phase 2 study, sponsored by Marinus Pharmaceuticals.
NCT01339689 is a Phase 2 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The CAPS total score is the sum of frequency and intensity ratings for each item and the score range was 0: no symptoms to 136: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug
Interventions
- DRUG Placebo
- DRUG Ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
What the finished NCT01339689 record still lists
NCT01339689 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01339689 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01339689's enrollment target sits among peer trials
112 631st of 2000 higher than 1,369 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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