Recruiting

Testing a new seizure medication for children and adults with Lennox-Gastaut syndrome

Plain-English translation of NCT05219617 on ClinicalTrials.gov ↗ · Source last updated July 2025 · 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 Lennox-Gastaut syndrome (LGS), a rare and serious type of epilepsy that usually starts in childhood. The study will give some participants the medication and others a placebo (an inactive pill) to compare how well this treatment works. Researchers will also track how safe and well-tolerated the medication is.

Lennox-Gastaut syndrome is a difficult-to-treat form of epilepsy where people experience many different types of seizures, including dangerous drop seizures that can cause falls and injuries. Even when patients take multiple anti-seizure medications, many still have breakthrough seizures, so there is a need for new treatment options.

Do you qualify?

You likely qualify if…

you have been diagnosed with Lennox-Gastaut syndrome with documented seizure types and specific brain wave patterns (EEG findings)
you are between 4 and 55 years old at the time of enrollment
you experienced at least 2 drop seizures (seizures affecting the whole body that cause falling or could cause injury) during the 4 weeks before the study starts
you are currently taking 1 to 4 anti-seizure medications at stable doses for at least 4 weeks
you or your caregiver can keep accurate daily records of your seizures

You likely don't qualify if…

your seizures are caused by a progressive neurologic disease (such as a growing brain tumor)
you have significant heart, lung, kidney, liver, or digestive system disease that could affect your safety
you were recently treated with ACTH (a hormone therapy for seizures)
you are pregnant, planning to become pregnant, or unable to use birth control during the study (if of childbearing potential)

What participation looks like

You will be randomly assigned to receive either the new medication at one of two doses, or a placebo that looks identical. You'll start with a lower dose and gradually increase to a maintenance dose over time while taking your current anti-seizure medications. Throughout the study, you or your caregiver will keep a daily seizure diary, and you'll have regular visits with the research team to check how the medication is working and monitor for any side effects. After the main part of the study ends, there's an option to continue in an open-label extension where all participants receive the active medication.

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

Trial locations(71 sites)

United States

Stanford University Hospital, Palo Alto, California

University of Florida Health Science Center, Jacksonville, Florida

AdventHealth, Orlando, Florida

Pediatric Epilepsy and Neurology Specialists, Tampa, Florida

University of South Florida, Tampa, Florida