Recruiting

Testing a new medicine to reduce seizures in children with Dravet syndrome

Plain-English translation of NCT06872125 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing , a new investigational medicine designed to help children with Dravet syndrome—a severe, hard-to-treat form of epilepsy. The medication works by increasing levels of a specific protein in the brain that is reduced in people with this condition. Researchers are studying whether this treatment can reduce the number and severity of seizures and improve overall quality of life.

Dravet syndrome is a rare genetic epilepsy that causes frequent, severe seizures and is often resistant to standard anti-seizure medications. This medication addresses the underlying genetic cause and aims to restore normal protein levels in the brain, offering the potential for better seizure control and long-term disease improvement.

Do you qualify?

You likely qualify if…

you are between 2 and 17 years old
you have been diagnosed with Dravet syndrome confirmed by an epilepsy specialist
you have a genetic change (variant) in the SCN1A gene
you have experienced multiple major motor seizures during an observation period
you have already tried at least two other seizure treatments (medications, special diets, or nerve stimulation) with limited success
you are currently taking at least one anti-seizure medication with stable dosing

You likely don't qualify if…

you have a specific type of SCN1A genetic change known as gain-of-function
you are currently taking certain anti-seizure medications that work by blocking sodium channels (such as phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, rufinamide, or cenobamate)
you are currently using other types of brain stimulation therapies (except vagus nerve stimulation)
you have had more than one hospitalization for seizures during the screening phase
you developed a new seizure type or had a seizure type reappear during the baseline period

What participation looks like

Participants will be randomly assigned to either receive the medication or a sham (inactive) treatment for approximately one year (Treatment Period 1). During this time, they will have regular study visits to check seizure frequency, behavior, thinking, and overall health. After the first year, all eligible participants will receive the active medication for a second treatment period. Throughout the trial, seizure counts and quality-of-life measures will be tracked to assess how well the treatment works.

AI-generated summary from trial data · Jun 1, 2026 · Not medical advice

Trial locations(61 sites)

United States

Phoenix Children's Hospital, Phoenix, Arizona

Arkansas Children's Hospital, Little Rock, Arkansas

Cedars Sinai Medical Center, Los Angeles, California

Children's Hospital of Orange County, Orange, California

USCF Medical Center, San Francisco, California