NCT05374824 Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome
| NCT ID | NCT05374824 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago |
| Condition | Lennox Gastaut Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,680 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,680 participants in total. It began in 2022-04-01 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Sandi Lam, MD MBA
PRINCIPAL INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Frequently Asked Questions
Who can join the NCT05374824 clinical trial?
This trial is open to participants of all sexes, up to 26 Years, studying Lennox Gastaut Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05374824 currently recruiting?
Yes, NCT05374824 is actively recruiting participants. Contact the research team at slam@luriechildrens.org for enrollment information.
Where is the NCT05374824 trial being conducted?
This trial is being conducted at Chicago, United States, Ann Arbor, United States, St Louis, United States, Columbus, United States.
Who is sponsoring the NCT05374824 clinical trial?
NCT05374824 is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. The principal investigator is Sandi Lam, MD MBA at Ann & Robert H Lurie Children's Hospital of Chicago. The trial plans to enroll 4,680 participants.