NCT00040326

Early Surgical Intervention to Treat Epilepsy

Early Randomized Surgical Epilepsy Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to compare the effectiveness of early surgical intervention for mesial temporal lobe epilepsy to continued treatment with antiepileptic drugs.

Detailed description

Mesial temporal lobe epilepsy (MTLE) is the most common form of epilepsy, and the most medically intractable. An estimated one-quarter to one-half of the 400,000 patients in the United States with intractable epilepsy have MTLE. Generally, MTLE becomes intractable in adolescence and early adulthood. Persistence of seizures during this time commonly causes adverse social and psychological consequences which can become irreversible. The current treatment of MTLE primarily consists of medications to control seizures. Usually surgical treatment is considered only if medications are not effective. Recent studies have shown that surgery can stop disabling seizures in 60 to 70% of patients with long standing MTLE. However, to date, no research study has examined surgery performed as an early therapy. The goal of the study is to determine if more patients treated with early surgery become seizure free and have improved quality of life compared to similar patients who continue to receive antiepileptic medication only. This study will determine the difference in seizure frequency between the two groups and the impact of the two treatments on the quality of life of the participants.

Conditions

• Epilepsy
• Epilepsy, Temporal Lobe
• Seizures

Interventions

Type	Name	Description
PROCEDURE	anteromesial temporal resection	surgical treatment for epilepsy
DRUG	antiepileptic drugs	pharmacotherapy

Timeline

• Start date: 2002-07-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2002-06-25
• Last updated: 2010-02-23

Locations

12 sites across 1 country: United States