An observational study in Lennox Gastaut Syndrome, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Completed at 7 sites in United States. Open to participants aged Up to 26 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Observational
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Among 38 studies in Lennox Gastaut Syndrome with a site in United States — 7 open to participants now, 10 under way, 4 of them phase 3. Lennox Gastaut Syndrome · United States.
Among the 38 studies in Lennox Gastaut Syndrome with a site in United States, this one is one of 6 that started in 2022, is one of 4 observational ones, and was the 30th registered.
68 studies on the registry are indexed under Lennox Gastaut Syndrome; 13 are open to participants now.
Browse Lennox Gastaut Syndrome studies →7 of the 38 studies in Lennox Gastaut Syndrome with a site in United States are open now. Recruiting first, the newest first:
Epygenix · Sites in United States, China, Hungary and 7 more countries
Ages 2–55
SK Life Science, Inc. · Sites in United States, Argentina, Australia and 13 more countries
Ages 4–55
University of Chicago · Sites in United States
Ages 2–35
Byteflies · Sites in United States
Ages 3+
Longboard Pharmaceuticals · Sites in United States, Australia, Belgium and 14 more countries
Ages 2–66
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 4 Lennox Gastaut Syndrome studies recruiting now, none set no upper age limit and 4 stop at 75 or younger; 3 take children under 18; none take healthy volunteers.
This study: Up to 26 Years · all sexes · no healthy volunteers.
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38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 7 · Phase 3 16 · Phase 4 2
First in 1992; this study’s year is marked. 6 started in 2022.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 52 across the 32 interventional studies, 394 across the 4 observational. Of the 26 that completed or were terminated, 15 (58%) have results posted.
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29 of 38 have an industry lead sponsor. The 10 most frequent:
Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 180 studies on the registry; 27 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Ann & Robert H Lurie Children's Hospital of Chicago has 1 study filed under Lennox Gastaut Syndrome — fewer than ten, so there is no comparison to draw.
5 of the studies in Lennox Gastaut Syndrome with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05219617Phase 3SK Life Science, Inc.Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults | 2027-02 |
| NCT06908226Phase 3Longboard PharmaceuticalsA Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE) | 2027-11-11 |
| NCT05339126NeuroPaceRNS System LGS Feasibility Study | 2026-11-30 |
| NCT06738732Alexander RotenbergCBD Delivery with the A-Synaptic GT4 Transdermal Delivery System in with Dravet Syndrome And/or Lennox-Gastaut Syndrome | 2027-01 |
| NCT05044819Jazz PharmaceuticalsAssessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution | 2027-08-01 |
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Among the 38 studies in Lennox Gastaut Syndrome with a site in United States, from their registry updates:
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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.
Background and Significance: Lennox-Gastaut Syndrome (LGS) is a rare developmental-epileptic encephalopathy characterized by life-long refractory seizures which result in frequent utilization of emergency healthcare resources and also contribute to the severe developmental and functional impairment ubiquitously seen in affected patients. Current treatment pathways are the addition of anti-seizure medication treatment or palliative surgical procedures (including neurostimulation), both of which have strong evidence supporting their effectiveness in reducing seizure frequency, but without cures. No evidence exists about the comparative effectiveness of these two pathways. Until such evidence is developed, parents and physicians will continue to struggle with difficult and daunting decisions about whether to add anti-seizure medications or to pursue palliative surgery, and when to do so.
Study Aims: Determine the comparative effectiveness of adding palliative surgery versus adding an LGS-approved medication (Aim 1a) for decreasing utilization of seizure-related emergency health care and (Aim 1b) for limiting the impairment of functional abilities. (Aim 2) Describe the frequency and patterns of utilization of the two therapy pathways at 18 PCORnet sites for variation over time and across sites as well as by patient features - age, medical fragility, race, ethnicity, and insurance type. In addressing these aims, the study will assess and improve PCORnet infrastructure and will enhance methods for future studies of LGS and other rare epilepsies.
Study Description: (Aim 1a) Observational retrospective cohort study of emergency health-care utilization and (Aim 1b) cross sectional study of the impact of treatment pathways on functional outcomes. (Aim 2) Retrospective open cohort study of frequency and patterns (by race, ethnicity, insurance, age) of utilization of the two treatment pathways.
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).
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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
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.
Time frame: 2 years
Parent-reported Clinical Outcome Assessments
Parent-reported qualitative input through descriptive assessment. The measures will be assessed once.
Time frame: 2 years
Plan to share: No
Ran from Apr 2022 to primary completion in Oct 2026, 54 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 13, 2026: primary completion Dec 2026 → Oct 2026 and completion Dec 2026 → Oct 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Ann & Robert H Lurie Children's Hospital of Chicago →