Status:
COMPLETED
Riluzole in Fragile X Syndrome
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Indiana Clinical and Translational Sciences Institute
Conditions:
Fragile X Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00895752
Start Date
April 1 2009
End Date
July 1 2010
Last Update
April 18 2017
Active Locations (1)
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1
Riley Child and Adolescent Psychiatry Clinic - Riley Hospital for Children
Indianapolis, Indiana, United States, 46202