Comparing surgery and medications for treating Lennox-Gastaut syndrome
Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome - PCORI
This study is testing whether surgery or extra medications work better for people with Lennox-Gastaut syndrome to help reduce seizures and improve their daily lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4680 (estimated) |
| Ages | N/A to 26 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 4 sites (Chicago, Illinois and 3 other locations) |
| Trial ID | NCT05374824 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of palliative surgery versus additional anti-seizure medications in patients with Lennox-Gastaut syndrome, a severe form of epilepsy. It will assess how these treatment options impact the frequency of seizure-related emergency healthcare utilization and the functional abilities of patients. The study will gather data from 18 PCORnet sites, focusing on variations in treatment patterns based on patient demographics and characteristics. By analyzing these approaches, the study seeks to provide valuable insights for parents and physicians in making informed treatment decisions.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Lennox-Gastaut syndrome who have medical records at participating pediatric centers.
Not a fit: Patients without a diagnosis of Lennox-Gastaut syndrome will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective treatment approach for reducing seizures and improving the quality of life for patients with Lennox-Gastaut syndrome.
How similar studies have performed: While there is strong evidence supporting the effectiveness of both treatment pathways, this study is novel as it seeks to directly compare their effectiveness in a systematic way.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 3 other locations
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States (Recruiting)
- St. Louis Children's Hospital — St Louis, Missouri, United States (Recruiting)
- Nationwide Children's — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Sandi Lam, MD MBA — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Sandi Lam, MD MBA
- Email: slam@luriechildrens.org
- Phone: 312 227 4220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.