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Which treatment tames LGS seizures better: surgery or more meds?

NCT ID NCT05374824

Disease control Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study looks at two ways to treat Lennox-Gastaut syndrome (LGS), a severe form of childhood epilepsy: adding more anti-seizure medications or undergoing palliative surgery (like a vagus nerve stimulator or corpus callosotomy). Researchers will track thousands of children across multiple hospitals to see which approach reduces seizure-related emergency visits and hospitalizations, and whether it helps with development and daily functioning. The goal is to give families clearer guidance on choosing the best treatment for their child.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Palliative surgery (vagus nerve stimulation or corpus callosotomy) versus additional anti-seizure medications
What this could lead to
If this trial succeeds, it could help families and doctors choose the best treatment approach for children with Lennox-Gastaut syndrome, potentially reducing seizures and improving quality of life.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may vary widely between individuals, and both treatments carry risks of side effects or complications.

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 4,680 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Dec 2026

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

For Aim 1a, 928 patients up to age 30 years with a chart-review validated diagnosis of Lennox-Gastaut Syndrome between 1/1/2016 and 12/31/2021 will be identified from 7 principal pediatric hospitals. For Aim 1b, a subset of half of those 928 patients (N=464) will be recruited. Analyses for Aim 2 will be based on ≥4000 patients with LGS ICD-10 codes from 18 pediatric hospitals (representing 5 PCORnet CRNs).

Ages

Up to 26 years

Sex

Anyone

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: Patients with the diagnosis of Lennox Gastaut syndrome with medical records at the seven plus eleven pediatric centers Exclusion Criteria: Patients without Lennox Gastaut Syndrome

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Conditions

The condition(s) this trial relates to.

epilepsy Lennox-Gastaut syndrome visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lennox Gastaut syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • C.S. Mott Children's Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Nationwide Children's

    RECRUITING

    Columbus, Ohio, 43205, United States

  • St. Louis Children's Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

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