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Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome

RecruitingPhase 2Ages 7 Years - 40 YearsAllUniversité de Sherbrooke
NCT06261502 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Most individuals with FXS have moderate to severe intellectual disability (ID), and caregivers are mainly concerned about aggressive behavior and anxiety problems. Since FXS individuals have a normal lifespan, the overall lifetime cost for the Canadian society of a single case is estimated at $1.2 to $4.7 millions reaching $18 billions for all FXS cases. There is no cure for FXS, as all clinical trials so far have been unsuccessful.FXS is caused by transcriptional silencing of the Fragile X mental retardation protein (FMR1) gene, making FXS a simple model to study ASD and ID pathophysiological mechanisms. Of those, neuronal hyperexcitability is largely recognized as a core deficit in FXS, and a c

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📋 Eligibility rules (as published)
Inclusion Criteria: * Molecular diagnosis of FXS * Age 7 to 40 inclusively * Overall ABC-C score \> 20 * Taking up to 3 psychoactive drugs * No therapeutic change for the last 3 months Exclusion Criteria: * Taking valproic acid * Taking clobazam * History of liver problems * aspartate aminotransferase (AST) or alanine transaminase (ALT), \> 3 times the reference values * Bilirubin \> 2 times the reference values * Absolute contraindication to the use of TMS and MRI (e.g. presence of metal in the body), will also be considered as an exclusion criterion.
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What it tests

  • CBD Oral Solution
  • Placebo
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Where

1 site
Universite de Sherbrooke, CHUS Research Center
Sherbrooke, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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