Can a CBD-Based drug stop seizures before they start?

NCT ID NCT07778810

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This trial tests whether Epidiolex, a prescription CBD medication, can delay or prevent the first seizure in infants with Sturge-Weber syndrome, a rare condition that often leads to seizures and developmental challenges. The study enrolls babies aged 1 to 18 months who have brain involvement but have not yet had seizures. Participants receive gradually increasing doses of Epidiolex over several weeks, and researchers monitor for safety and whether seizures are delayed or avoided.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epidiolex (cannabidiol, CBD) oral solution
What this could lead to
If successful, this could lead to a preventive treatment that delays or stops seizures in infants with Sturge-Weber syndrome, potentially improving their neurological development and quality of life.
What could go wrong
This is a small pilot study with only 10 participants, so results may not apply broadly. The drug may not prevent seizures, and side effects like liver issues or sedation 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 10 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 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

1 month to 18 months

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: * Clinical diagnosis of Sturge-Weber Syndrome. * Age 1 to 18 months of age, inclusive. * Neuroimaging demonstrating involvement of 3 or more lobes, or bilateral involvement. * No history of seizures. * Patient's parent or legal guardian provides written informed consent prior to treatment initiation. Exclusion Criteria: Any severe and/or uncontrolled medical conditions at randomization including, but not limited to the following: * Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBVDNA and/or positive HbsAg, quantifiable HCV-RNA). Specifically the patient should not have either AST or ALT more than 1.5 times the upper limit of normal. The Child- Pugh Score must be A (mild) which is a score of 5-6 (minimum/normal score=5). Child-Turcotte-Pugh (CTP) Calculator - Clinical Calculators - Hepatitis C Online (uw.edu) * Uncontrolled diabetes as defined by fasting serum glucose \> 1.5 ULN * Active (acute or chronic) or uncontrolled severe infections * Active, bleeding diathesis * Any other neurological diagnosis that increases the risk of seizure or neurodevelopmental disability. * Patients who have had a major surgery or significant traumatic injury within 4 weeks of study entry, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients that may require major surgery during the course of the study. * Prior treatment with any investigational drug or use of any other cannabis product within the preceding 4 weeks prior to study entry. * Use of aspirin. * Allergic reaction/hypersensitivity to Epidiolex or other forms of cannabidiol. * Concern for non-compliance to medical regimens, or concern that the patient will not be able to complete the entire study, whether due to reliability or logistical barriers. This includes those in foster care, or those unable to keep follow-up appointments, maintain close contact with Principal Investigator, or complete all necessary studies to maintain safety. * Use of any seizure medication (whether for seizures or any other reason) (e.g. valproate, clobazam). * Use of chronic medications other than a multi-vitamin and/or vitamin D supplements.

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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.

    Open the record ↗

  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

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21205, United States

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