Phase 4
Completed N=6
Riluzole in Fragile X Syndrome
Source: ClinicalTrials.gov NCT00895752 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Clinical Global Impression-Improvement (CGI-I) — 3.5 units on a scale
◆ Published Evidence
Established
65citations · ~4 / year
Open-label riluzole in fragile X syndrome.
Summary
The purpose of this study is to investigate the effectiveness and tolerability of riluzole in adults with Fragile X Syndrome.
Linked Publications
-
Open-label riluzole in fragile X syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression-Improvement (CGI-I) |
3.5 | — |
| PRIMARY Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) |
11.2; 9.7 | — |
| SECONDARY Aberrant Behavior Checklist |
8.3; 9.7; 5.3; 15.0; 6.2 | — |
| SECONDARY The ADHD Rating Scale |
19.0 | — |
| SECONDARY The Clinical Global Impression - Severity Scale |
4.2 | — |
| SECONDARY The Peabody Picture Vocabulary Test |
123.2 | — |
| SECONDARY The Social Reciprocity Scale |
103.5 | — |
| SECONDARY Extra-cellular Signal-relatedness Kinase (ERK) |
2.99 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00895752) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.