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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00040326 |
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.
Condition | Intervention | Phase |
---|---|---|
Epilepsy Epilepsy, Temporal Lobe Seizures |
Procedure: anteromesial temporal resection Drug: antiepileptic drugs |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment |
Official Title: | Early Randomized Surgical Epilepsy Trial |
Estimated Enrollment: | 200 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | November 2007 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
anteromesial temporal resection
|
Procedure: anteromesial temporal resection
surgical treatment for epilepsy
|
2: Active Comparator
antiepileptic drugs
|
Drug: antiepileptic drugs
pharmacotherapy
|
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.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
United States, Arizona | |
Barrow Neurological Institute | |
Phoenix, Arizona, United States, 85013 | |
United States, California | |
UCLA School of Medicine, Department of Neurology | |
Los Angeles, California, United States, 90095-1769 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Michigan | |
University of Michigan, Department of Neurology | |
Ann Arbor, Michigan, United States, 48109-0036 | |
United States, New York | |
University of Rochester, Department of Neurology | |
Rochester, New York, United States, 14642 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37212 | |
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908 | |
United States, Washington | |
Swedish Medical Center | |
Seattle, Washington, United States, 98122 |
Principal Investigator: | Jerome Engel, Jr., M.D., Ph.D. | UCLA School of Medicine, Department of Neurology |
Study ID Numbers: | R01NS42372 |
Study First Received: | June 24, 2002 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00040326 |
Health Authority: | United States: Federal Government |
epilepsy mesial temporal lobe epilepsy temporal lobe epilepsy MTLE seizures |
anteromesial temporal resection surgery antiepileptic drugs hippocampal sclerosis |
Epilepsies, Partial Signs and Symptoms Epilepsy Seizures Neurologic Manifestations |
Central Nervous System Diseases Sclerosis Brain Diseases Epilepsy, Temporal Lobe |
Nervous System Diseases |