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. About 150 people will participate in this study, which lasts 20 weeks, to see if this medication is safe and whether it helps reduce how often seizures happen. Half of participants will receive the new medication, and half will receive a placebo (a pill with no active medicine) so researchers can fairly compare the results.
Dravet syndrome is a severe form of epilepsy that begins in infancy and can be very difficult to treat with existing anti-seizure medications. This trial exists because many people with Dravet syndrome continue to have breakthrough seizures even while taking multiple drugs, and researchers want to find new treatment options that could help reduce these dangerous seizures.
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You will start with a 4-week observation period where researchers track your current seizure activity while you continue your regular medications. Then you'll enter a 16-week treatment phase where you'll take either the new medication or a placebo (neither you nor your doctor will know which one initially) in addition to your current anti-seizure drugs. You'll have study visits to check how you're doing, report any side effects, and track your seizure count. If the medication appears to be working well and you want to continue, you may join an optional extension phase where you can receive the actual medication for up to 3 years.
AI-generated summary from trial data · Jun 1, 2026 · Not medical advice
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