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EEG clues may reveal who benefits from seizure drug

NCT ID NCT07555171

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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.