NCT00895752

Riluzole in Fragile X Syndrome

Riluzole in Fragile X Syndrome: A Pilot Study Incorporating Biomarker Assay

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effectiveness and tolerability of riluzole in adults with Fragile X Syndrome.

Detailed description

Fragile X Syndrome (FXS) represents the most common inherited form of intellectual disability. FXS is more common in males and the symptoms associated with the disorder are more marked in males. FXS is associated with characteristic physical features, behaviors, and comorbidities. Those with FXS often suffer from behavioral difficulties that include anxiety-related symptoms (shyness, social phobia, obsessive-compulsive disorder (OCD) symptoms), attention deficit hyperactivity symptoms (overarousal, hyperactivity, distractibility, impulsivity) and aggressive/self-injurious behaviors. Riluzole is approved by the FDA for use in treating amyotrophic lateral sclerosis (ALS) in adults. Recently, riluzole has been the subject of several open-label studies describing the use of the drug in treatment-resistant depression and OCD. Given the overlap between repetitive behavior in FXS and symptoms of OCD, it is logical to study riluzole in FXS given the compound's promise in ameliorating treatment-refractory symptoms of OCD.

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	Riluzole	Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-05-08
• Last updated: 2017-04-18
• Results posted: 2017-04-18

Locations

1 site across 1 country: United States