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Ganaxolone Treatment in Children With Fragile X Syndrome

NCT01725152 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-04-10

Study results available
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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.

Conditions

  • Fragile x Syndrome

Interventions

DRUG

Ganaxolone

oral suspension, given in 3 divided doses

DRUG

Placebo

oral suspension, given in 3 divided doses

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Marinus Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-10-16
Completion
2016-11-01

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01725152 on ClinicalTrials.gov