Plain-English translation of NCT04462770 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · 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.
This trial is testing clemizole hydrochloride as an add-on treatment for people with Dravet Syndrome whose seizures aren't fully controlled by their current medications. Researchers want to see if this medication can safely reduce seizures when used alongside the treatments you're already taking. About 150 participants worldwide will join this 20-week study.
Dravet Syndrome is a rare, severe form of epilepsy that starts in infancy, and many people continue to have seizures even while taking multiple anti-seizure drugs. This trial is exploring whether this medication could offer better seizure control for patients who haven't found adequate relief with their current treatments.
You likely qualify if…
You likely don't qualify if…
You'll start with a 4-week observation period where researchers track your current seizure activity. Then you'll enter a 16-week treatment phase where you'll randomly receive either the new medication or a placebo (a dummy pill) in addition to your regular anti-seizure drugs — neither you nor your doctor will know which one at first. If you complete this phase, you can choose to continue in an extended period where everyone receives the active medication for up to 3 years.
AI-generated summary from trial data · Jul 6, 2026 · Not medical advice
United States