Can CBD calm the brain in fragile x syndrome?

NCT ID NCT06261502

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

7 to 40 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. 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

  • Universite de Sherbrooke, CHUS Research Center

    RECRUITING

    Sherbrooke, Quebec, J1H5N4, Canada

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