NCT05374824: SOM-L

Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome

Recruiting now Last updated 16 July 2024

What this trial tests

trial in Lennox Gastaut Syndrome in 4,680 participants. Currently enrolling.

Timeline

1 April 2022

Primary endpoint
31 March 2025

31 August 2025

Quick facts

Lead sponsor	Ann & Robert H Lurie Children's Hospital of Chicago
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	4,680
Start date	1 April 2022
Primary completion	31 March 2025
Estimated completion	31 August 2025
Sites	4 locations across United States

Conditions studied

• Lennox Gastaut Syndrome — all drugs for Lennox Gastaut Syndrome →

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Who can join

Under 26, any sex, with Lennox Gastaut Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Lennox-Gastaut syndrome is a serious and rare form of epilepsy that begins in infancy and early childhood. Seizures and their consequences need medical attention, emergency encounters, and hospitalizations. Seizures disrupt home life for the patient and for family. Lennox-Gastaut syndrome is typically accompanied by disabilities in motor, communication, eating, and other skills needed for daily function.

Lennox-Gastaut syndrome (LGS) has no cure. Although current treatments may help reduce the number of seizures, none are expected to eliminate them entirely; these treatments are palliative. The main treatments include anti-seizure medications and some surgical approaches, including the implantation of a vagus nerve stimulator (a pacemaker-like generator implanted in the chest wall and programmed by a physician to stimulate the vagus nerve in the neck) and corpus callosotomy (cutting through the band of fibers that connect the two sides of the brain). While both types of treatment (medications and surgeries) produce some benefit by reducing how often the seizures occur, both also have some risks. All medications can, in some patients, produce moderate to severe side effects. This is true of anti-seizure medications. Most patients with LGS take several anti-seizure medications at a time. Surgeries can also have associated risks and is additionally stressful for parents and family members. Currently, there is no strong evidence to support parents and physicians in deciding which type of treatment (more medicines or surgery) will be most successful for a child with LGS, and whether one or the other approach may lessen the toll that seizures take on a child's development and ability to function.

This study has two components. It will engage a network of seven pediatric hospitals in the United States where children with Lennox-Gastaut syndrome are cared for and determine whether seizure-related emergency department visits and hospitalizations are more likely to be reduced following the use of additional medications or adding palliative surgery to existing medications. The investigators will determine whether medical versus surgical treatment is more likely to lessen some of the developmental and functional difficulties that affect patients with LGS. The study will also determine whether starting therapies at a younger versus older age makes a difference.

The second component of the study will provide a description of the use of surgical versus medical treatment approaches across 18 pediatric hospitals in the United States (seven plus 11 centers). The investigators will describe how treatments differ across hospitals and over time.

The results from this study will help parents and providers make more informed choices about treatment for children with Lennox-Gastaut syndrome and will highlight areas for improvement in providing the best possible health care for this severe, lifelong disorder.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical trials for Lennox-Gastaut syndrome: Challenges and priorities.
   Knowles JK, Warren AEL, Mohamed IS, Stafstrom CE, et al · · 2024 · cited 17× · PMID 39440617 · DOI 10.1002/acn3.52211
2. Mobilizing a New Era in Lennox-Gastaut Syndrome Treatment and Prevention.
   Warren AEL, Patel AD, Helen Cross J, Clarke DF, et al · · 2025 · cited 4× · PMID 40161505 · DOI 10.1177/15357597251321926
3. Comparative effectiveness of epilepsy surgery versus additional anti-seizure medications for Lennox-Gastaut syndrome: study protocol for a multicenter, mixed-methods study.
   Lam S, Rosenman M, Dixon-Salazar T, Knupp KG, et al · · 2025 · cited 1× · PMID 40606139 · DOI 10.3389/fneur.2025.1569551