Can CBD calm the brain in fragile x syndrome?
NCT ID NCT06261502
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This phase 2 trial tests whether a daily oral CBD solution can reduce anxiety and disruptive behavior in people with Fragile X syndrome, a genetic condition that often causes intellectual disability and autism-like symptoms. Researchers will give 40 participants either CBD or a placebo for several weeks, then measure changes in anxiety, behavior, and brain inhibition using questionnaires and brain stimulation. The goal is to see if CBD can correct a known brain imbalance that may drive these symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CBD oral solution
- What this could lead to
- If it works, CBD could become a treatment to reduce anxiety and disruptive behavior in Fragile X syndrome, a condition with no approved therapies for these symptoms.
- What could go wrong
- This is a small, early-stage trial with 40 participants. CBD may not improve symptoms, and side effects like liver issues or interactions with other drugs are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Universite de Sherbrooke, CHUS Research Center
RECRUITINGSherbrooke, Quebec, J1H5N4, Canada
More trials for these conditions
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- Can early parent coaching help infants with rare genetic disorders thrive?
- Experimental drug aims to boost brain function in fragile x syndrome
- Newborn screening study aims to catch rare diseases at birth
- New drug trial aims to ease fragile x symptoms in men