Recruiting

Testing a New Seizure Medication for Dravet Syndrome

Plain-English translation of NCT06660394 on ClinicalTrials.gov ↗ · Source last updated July 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 medication called to see if it can help reduce seizures in people with Dravet syndrome, a rare and serious form of epilepsy that usually starts in infancy. Researchers want to understand whether this medication is safe and effective when added to the treatments people are already taking. Half of the participants will receive the new medication, and half will receive a placebo (a pill with no active medicine) to see if the real medication works better.

Dravet syndrome is a severe type of epilepsy where people continue to have frequent, unpredictable seizures even when taking multiple medications. This trial exists because doctors and patients need new treatment options to better control these seizures and improve quality of life.

Do you qualify?

You likely qualify if…

you have been diagnosed with Dravet syndrome with seizures that started between ages 1 and 20 months
you have been experiencing at least 4 countable motor seizures per month for the 3 months before enrolling
you are currently taking 1 to 4 seizure medications at a stable dose for at least 4 weeks
you (or your parent or caregiver) are able and willing to keep detailed seizure diaries throughout the study
you are willing and able to provide informed consent to participate

You likely don't qualify if…

you have a history of infantile spasms (a specific type of seizure that occurs in very young children)
you have been hospitalized within the last 3 months for a severe, prolonged seizure requiring breathing support
you have a neurodegenerative disorder or brain injury unrelated to Dravet syndrome
you are currently using cannabis or cannabis-derived products that do not meet strict safety requirements
you have other serious medical conditions (heart, lung, liver, kidney, or psychiatric) that could make participation unsafe

What participation looks like

You will visit the study site multiple times over about 24 months. First, there is a screening period to confirm you qualify. Then you will enter a titration phase where your dose is slowly increased to find the best dose for you (or you'll receive placebo). After that, you'll stay on a stable dose during a maintenance phase. Throughout the study, you'll keep careful records of your seizures, have regular check-ups, and then gradually taper off the medication at the end. Researchers will monitor how well the medication works and check for any side effects.

AI-generated summary from trial data · Jun 12, 2026 · Not medical advice

Trial locations(102 sites)

United States

Arkansas Children's Hospital - PIN, Little Rock, Arkansas

Children's Hospital Los Angeles - PIN, Los Angeles, California

David Geffen School of Medicine at UCLA, Los Angeles, California

The Stanford Division of Child Neurology, Palo Alto, California

UCSF Children's Hospital, San Francisco, California