EEG clues may reveal who benefits from seizure drug
NCT ID NCT07555171
First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 4 times
Summary
This study looks at whether specific brain wave patterns on an EEG can predict how well the drug fenfluramine works for people with Lennox-Gastaut Syndrome (LGS), a severe form of epilepsy. Researchers will follow 20 children and adults aged 2 to 35 who are already taking fenfluramine. The goal is to find EEG markers that show if the drug is helping, giving doctors a better way to tailor treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fenfluramine
- What this could lead to
- If successful, this could help doctors predict which LGS patients will benefit most from fenfluramine, personalizing treatment.
- What could go wrong
- This is a small, early-stage observational study with only 20 participants, so results may not apply broadly. It focuses on markers, not a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2026
- Expected to finish
-
Apr 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients at University of Chicago who have been diagnosed with Lennox-Gastaut Syndrome (LGS)
- Ages
-
2 to 35 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Children and adults aged 2 to 35 years * Have a confirmed diagnosis of Lennox-Gastaut Syndrome (LGS), validated by the Epilepsy Study Consortium * Documented seizure onset at age 11 years or younger, accompanied by multiple seizure types, specifically including tonic seizures and atonic or tonicatonic seizures. * Participants must exhibit a stable seizure baseline for at least 4 weeks prior to enrollment, with documented frequency of two or more drop seizures per week, characterized as generalized tonic-clonic (GTC), secondary GTC (focal to bilateral tonic-clonic seizures), tonic, atonic, or combined tonic-atonic seizures. * Participants must exhibit abnormal cognitive development and a medical history consistent with electroencephalographic (EEG) findings demonstrating abnormal background activity characterized by a slow spike-andwave pattern at a frequency of less than 2.5 Hz. * Participants must have a clearly documented etiology of LGS falling into one of the following categories: structural, genetic, metabolic, infectious, immune or unknown. * Participants must have had a valid baseline EEG that reflects their clinical state during a stable seizure period and must have been conducted within 6 months prior to study enrollment. * Participants must be currently receiving fenfluramine as part of their clinical management regimen. Fenfluramine dosing must follow established LGS-specific dosing guidelines, initiated at 0.1 mg/kg administered orally twice daily, with weekly dose titration based on tolerability and clinical response until reaching the recommended maintenance dose of 0.35 mg/kg orally twice daily, not exceeding a total daily dose of 26 mg. * At the time of enrollment, participants must have been on a stable antiseizure medication (ASM) regimen for at least 30 days, defined as receiving between one and four concomitant ASMs without any recent medication changes, aside from the addition of fenfluramine. To ensure accurate baseline EEG assessments, participants must have a documented EEG recorded within 6 months (±2 months) prior to initiation of fenfluramine treatment. * Caregivers or legal guardians must provide informed consent, and participant assent will be obtained when developmentally appropriate according to ethical standards. Exclusion Criteria: * Patients have been diagnosed with any progressive neurodegenerative disorders, as these conditions could confound the interpretation of fenfluramine's clinical efficacy and safety profile. * Individuals with a documented history of fenfluramine use prior to obtaining baseline EEG will be excluded to ensure the baseline EEG data accurately represent the pre-treatment neurophysiological state. * Participants who have incomplete medical records, inadequate EEG documentation, or insufficient diagnostic workup confirming LGS diagnosis.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Lennox-Gastaut syndrome (LGS) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Chicago
Chicago, Illinois, 60637, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an experimental drug cut drop seizures in a severe childhood epilepsy?
- Can a new drug tame seizures in two severe epilepsy syndromes?
- How many people live with rare epilepsies in spain? a nationwide count aims to find out
- Counting the uncounted: a nationwide look at two rare epilepsies
- Smart brain pacemaker aims to stop seizures while you sleep
- Brain pacemaker trial aims to cut seizures in kids with severe epilepsy