Early Surgical Intervention to Treat Epilepsy

Phase 3

Completed

• Conditions: Epilepsy; Epilepsy, Temporal Lobe; Seizures
• Interventions: Drug: antiepileptic drugs; Procedure: anteromesial temporal resection

• Registration Number: NCT00040326
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Study Timeline

• Study First Submitted: 2002-06-24
• Study First Submitted QC: 2002-06-24
• Study First Posted: 2002-06-25
• Study Start: 2002-07
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-22
• Last Update Posted: 2010-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	antiepileptic drugs	antiepileptic drugs
1	anteromesial temporal resection	anteromesial temporal resection

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be freedom from disabling epileptic seizures (complex partial and secondarily generalized seizures, and simple partial seizures that are apparent to an observer)	2 years

Trial Locations

Locations (12)

University of Michigan, Department of Neurology; 🇺🇸 Ann Arbor, Michigan, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Rochester, Department of Neurology; 🇺🇸 Rochester, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

UCLA School of Medicine, Department of Neurology; 🇺🇸 Los Angeles, California, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States