Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome
SOM-L
2 other identifiers
observational
4,680
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 6, 2022
CompletedFirst Posted
Study publicly available on registry
May 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedJuly 16, 2024
July 1, 2024
3 years
May 6, 2022
July 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seizure-related emergency health care utilization
Emergency health-care utilization for Aim 1a will be defined as the frequency per year of seizure-related emergency department visits and separately seizure-related inpatient admissions in the two years postintervention (surgery or medical), with adjustment for the rate during the year prior to intervention.
2 years
Secondary Outcomes (1)
Parent-reported Clinical Outcome Assessments
2 years
Eligibility Criteria
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).
You may qualify if:
- Patients with the diagnosis of Lennox Gastaut syndrome with medical records at the seven plus eleven pediatric centers
You may not qualify if:
- Patients without Lennox Gastaut Syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicagolead
- Patient-Centered Outcomes Research Institutecollaborator
- Nationwide Children's Hospitalcollaborator
- University of Colorado, Denvercollaborator
- University of Michigancollaborator
- University of Pittsburghcollaborator
- Seattle Children's Hospitalcollaborator
- St. Louis Children's Hospitalcollaborator
- University of Cincinnaticollaborator
- Nemours Children's Health Systemcollaborator
- Stanford Universitycollaborator
- Monroe Carell Jr. Children's Hospital at Vanderbiltcollaborator
- University of North Carolinacollaborator
- Duke Universitycollaborator
- Indiana Universitycollaborator
- Johns Hopkins Universitycollaborator
- Nicklaus Children's Hospital f/k/a Miami Children's Hospitalcollaborator
Study Sites (4)
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Nationwide Children's
Columbus, Ohio, 43205, United States
Related Publications (1)
Lam S, Rosenman M, Dixon-Salazar T, Knupp KG, Thio LL, Abel TJ, Welch WP, Reed L, Randle SC, Garcia-Sosa R, Hauptman JS, Foster CC, Alpern ER, Zhang L, Villalba N, Carroll M, Patel AD. Comparative effectiveness of epilepsy surgery versus additional anti-seizure medications for Lennox-Gastaut syndrome: study protocol for a multicenter, mixed-methods study. Front Neurol. 2025 Jun 18;16:1569551. doi: 10.3389/fneur.2025.1569551. eCollection 2025.
PMID: 40606139DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandi Lam, MD MBA
Ann and Robert H. Lurie Children's Hospital of Chicago
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Division of Pediatric Neurosurgery
Study Record Dates
First Submitted
May 6, 2022
First Posted
May 16, 2022
Study Start
April 1, 2022
Primary Completion
March 31, 2025
Study Completion
August 31, 2025
Last Updated
July 16, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share