By InvitationNot Applicable

EEG Dynamics in Lennox-Gastaut Syndrome Patients Undergoing Fenfluramine Treatment

United States20 participantsStarted 2026-04

Plain-language summary

This study plans to learn if certain markers found during electroencephalogram (EEG) analysis could predict fenfluramine responsiveness to give clinicians greater insight into the effectiveness of fenfluramine in people with Lennox Gastaut Syndrome (LGS).

Who can participate

Age range

2 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants who have concordance between electroencephalogram (EEG) changes and clinical responsiveness in patients diagnosed with Lennox-Gastaut Syndrome (LGS) undergoing treatment with fenfluramine after 6 months.

Timeframe: from EEG prior to fenfluarmine initiation to follow up EEG 6 months after

Trial details

NCT IDNCT07555171

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Lennox Gastaut Syndrome (LGS) trials