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 range2 Years – 35 Years
SexALL
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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…
What they're measuring
1
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