Riluzole in Fragile X Syndrome

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: Indiana Clinical and Translational Sciences Institute
• Treatments: Riluzole

Criteria

Inclusion Criteria:

• Males and females age 18 years or older.

• Confirmed molecular diagnosis of Fragile X Syndrome.

• Clinical Global Impression Severity (CGI-S) score of 3 or greater.

• Significant interfering repetitive behavior as determined by the principal investigator.

• Must be in good health as determined by screening procedures including a detailed medical history, and complete physical and neurological examination.

• Dosing of concomitant medications during the study must remain stable.

Exclusion Criteria:

• Pregnancy.

• Concomitant use of another glutamatergic agent (memantine, topiramate, amantadine, among others.

• Evidence of prior trial of riluzole and/or hypersensitivity/allergic reaction to riluzole.

• Abnormal baseline liver function tests at screen or by history; or complete blood count abnormalities at screen or by history.