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Can a Cannabis-Based drug calm the Brain's nighttime storm in children?

NCT ID NCT04721691

Disease control Sponsor: Northwell Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests whether Epidiolex, a purified form of cannabidiol, can reduce the abnormal brain activity seen in children with electrical status epilepticus of sleep (ESES). ESES causes continuous seizure-like spikes on EEG during sleep, which can affect learning and behavior. The study enrolls children aged 2 to 17 and uses a double-blind, placebo-controlled crossover design, meaning each child receives both the drug and a placebo at different times. Researchers measure changes in spike wave index using 24-hour EEG recordings and also track seizure counts and behavior changes.

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) oral solution
What this could lead to
If effective, Epidiolex could offer a new treatment option to reduce the abnormal brain activity and seizures in children with ESES, potentially improving their sleep and cognitive function.
What could go wrong
This is a very small, early-phase trial with only 16 participants. The results may not apply to all children with ESES, and Epidiolex can have side effects like drowsiness or liver issues.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Mar 2021

Finished

Jan 2024

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

2 to 17 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.

In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 2-17 years old 4. In good general health as evidenced by medical history or diagnosed with ESES. "Good health" in relation to this study is understood as stable without current seizures requiring immediate hospitalization. 5. Ability to take oral medication and be willing to adhere to the Epidiolex/Placebo regimen 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 month after the end of oral Epidiolex administration 7. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner Exclusion Criteria:An individual who meets any of the following criteria will be excluded from participation in this study: 1. Previous use of cannabidiol within 4 months. 2. Pregnancy or lactation 3. Known allergic reactions to components of the Epidiolex: cannabidiol, sesame seed oil, and sucralose 4. Febrile illness within 1 month of screening 5. Treatment with another investigational drug or other intervention within 6 months 6. Current smoker or tobacco use within 6 months

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Conditions

The condition(s) this trial relates to.

developmental and/or epileptic encephalopathy with spike-wave activation in sleep

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Electrical status epilepticus of slow-wave sleep

Contacts and locations

Locations

  • Northwell Health

    Lake Success, New York, 11042, United States