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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00895752 |
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Date of registration:
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06/05/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Riluzole in Fragile X Syndrome
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Scientific title:
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Riluzole in Fragile X Syndrome: A Pilot Study Incorporating Biomarker Assay |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00895752 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Craig A. Erickson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indiana University School of Medicine |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fragile X Syndrome
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Intervention(s)
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Drug: Riluzole
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Primary Outcome(s)
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Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
[Time Frame: Obtained at Baseline and Week 6]
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Clinical Global Impression-Improvement (CGI-I)
[Time Frame: Obtained at Week 6]
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Secondary Outcome(s)
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The Peabody Picture Vocabulary Test
[Time Frame: Week 6]
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The ADHD Rating Scale
[Time Frame: Week 6]
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Extra-cellular Signal-relatedness Kinase (ERK)
[Time Frame: Screen and Week 6]
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The Clinical Global Impression - Severity Scale
[Time Frame: Week 6]
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Aberrant Behavior Checklist
[Time Frame: Week 6]
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The Social Reciprocity Scale
[Time Frame: Week 6]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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