Riluzole in Fragile X Syndrome
Completed · Phase 4
Conditions studied: Fragile X Syndrome
In brief
The purpose of this study is to investigate the effectiveness and tolerability of riluzole in adults with Fragile X Syndrome.
Key facts
- Study ID
- NCT00895752
- Run by
- Indiana University
- People needed
- 6
- Starts
- 2009-04-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2017-04-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Riley Child and Adolescent Psychiatry Clinic - Riley Hospital for Children — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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