Buspirone Therapy for Localized Epilepsy

OBJECTIVE: To initiate a pilot clinical trial assessing the safety, tolerability and efficacy of the 5HT1A receptor agonist buspirone in patients with localization-related epilepsy. Buspirone is a 5HT1A receptor agonist that is approved for the treatment of anxiety disorders. Patients with localization-related epilepsy have reduced 5HT1A receptor binding on 18FCWAY positron emission tomography (PET). Increasing neurotransmitter activity at 5HT1A receptor sites may ameliorate seizures. STUDY POPULATION: Forty patients with localization-related epilepsy DESIGN: A randomised, double-blind, placebo-controlled cross-over, phase II clinical trial. The trial will have a screening phase in which each patient will undergo physical and neurological examination, and standard blood tests, followed by a one month baseline phase. At the end of baseline, patients who qualify will have neuropsychological, anxiety, and mood evaluation, FCWAY PET and MRI (if imaging was not performed already). During the subsequent first study phase, patients will be randomized to buspirone or matching placebo. After completion of the first study phase, patients will be crossed over to the alternate study arm. At the end of the study, any patient who wishes to do so may remain on open-label buspirone. OUTCOME MEASURES: 1. Difference in seizure rate comparing the 3 month placebo and active study phases 2. Neuropsychological, anxiety, and mood indices comparing the 3 month placebo and active study drug phases