Cannabidiol for Anxiety and GABA Function in Fragile X Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial explores the effects of CANnabidiol (CBD) oral solution versus placebo in individuals with Fragile X syndrome. Adults and children aged 7 to 40 with Fragile X will be enrolled to examine changes in anxiety and GABAergic function, using assessments that may include neurophysiological and imaging measures. The study incorporates noninvasive brain stimulation and MRI techniques to understand how CBD impacts neural excitability linked to Fragile X. Participants will continue their existing medications unless changes are clinically necessary, with safety monitored through laboratory tests and adverse event reporting. The trial is led by Université de Sherbrooke with CIHR and industry collaboration, at a Sherbrooke-based research center.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universite de Sherbrooke, CHUS Research Center
  Sherbrooke, Quebec, Canada Recruiting

Study contacts

• Study coordinator: François Corbin, MD, Ph.D.
• Email: Francois.Corbin@USherbrooke.ca
• Phone: 819-346-1110

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.