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Your journey
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More info
You can access this
clinical trial
if you have
Fragile x Syndrome
and you are
between 6 and 17
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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). Up to 60 subjects (ages 6-17 yrs) will be randomized to receive either ganaxolone or placebo for 6 weeks and then cross over to the opposite treatment for another 6 weeks. The aim of the study is assess the safety, tolerability and efficacy of ganaxolone for treatment of anxiety and attention in subjects with FXS. The hypothesis is that ganaxolone treatment compared to placebo will improve anxiety and attention as measured by the several neuropsychological and psychometric tests.

Provided treatments

  • Drug: Ganaxolone
  • Drug: Placebo

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01725152. The sponsor of the trial is Marinus Pharmaceuticals and it is looking for 59 volunteers for the current phase.
Official trial title:
A Controlled, Double-blind, Crossover Trial of Ganaxolone in Children With Fragile X Syndrome