CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Ganaxolone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01725152
NCT01725152Phase 2Completed
CompareCT.gov

A Controlled, Double-blind, Crossover Trial of Ganaxolone in Children With Fragile X Syndrome

Marinus Pharmaceuticals·interventional·Posted Nov 12, 2012·Updated Apr 10, 2023

In Brief

A Phase 2 clinical trial evaluating Ganaxolone and Placebo for Fragile x Syndrome. Completed, enrolled 59 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFragile x Syndrome
CountriesBelgium, United States
CollaboratorsUniversity of California, Davis, U.S. Army Medical Research and Development Command

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 12, 2012
Enrollment StartNov 1, 2012
Primary CompletionOct 16, 2015
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 13.6 years ago

Interventions

Ganaxolonedrug

oral suspension, given in 3 divided doses

Placebodrug

oral suspension, given in 3 divided doses