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NCT01725152 · ClinicalTrials.gov registry record · Phase 2
Ganaxolone Treatment in Children With Fragile X Syndrome
A Phase 2 study, sponsored by Marinus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT01725152: Completed Phase 2 study, sponsored by Marinus Pharmaceuticals.
NCT01725152 is a Phase 2 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01725152, a Phase 2 study, has completed, sponsored by Marinus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, crossover study to investigate ganaxolone treatment in children with fragile x syndrome (FXS). The objective of the study is to assess the safety, tolerability and efficacy of ganaxolone in the treatment of anxiety and attention in subjects with FXS.
Primary Outcome
The CGI-I scale is a clinician-rated 7-point scale used to assess how much the participant's illness had improved or worsened relative to a Baseline state at the beginning of the intervention. It was rated as: 1. "very much improved"; 2. "much improved"; 3. "minimally improved"; 4. "no change"; 5. "minimally worse"; 6. "much worse"; 7. "very much worse". Higher scores indicated worse condition.
Interventions
- DRUG Placebo
- DRUG Ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-11 |
| Est. Completion | 2016-11-01 |
| Phase | Phase 2 |
What the finished NCT01725152 record still lists
NCT01725152 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01725152 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01725152 about?
NCT01725152 is a clinical study titled "Ganaxolone Treatment in Children With Fragile X Syndrome". This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, crossover study to investigate ganaxolone treatment in children with fragile x syndrome (FXS). The objective of the study is to assess the safety, tolerability and efficacy of ganaxolone in the treatment of anxiet...
What is the current status of trial NCT01725152?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2012-11. Estimated completion is 2016-11-01.
What interventions are being tested in trial NCT01725152?
The interventions under investigation include: Placebo (DRUG), Ganaxolone (DRUG).
Who is sponsoring clinical trial NCT01725152?
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 NCT01725152's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 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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