Role of Hormones in Susceptibility to Seizures in Women With Epilepsy

INCLUSION CRITERIA: Group A subjects will be 8 women between 18 and 45 years of age who have complex partial seizures with Type 1 catamenial seizure exacerbation as previously defined. Group B subjects will be 8 women between 18 and 45 years of age with complex partial seizures who do not meet the criteria for catamenial seizure exacerbations. The presence or absence of Type 1 catamenial seizure exacerbation will be documented by a standard seizure calendar self-reported for at least two consecutive menstrual cycles. Patients receiving antiepileptic drug therapy will continue on their medications. All subjects must agree to use double barrier contraceptives, have an intrauterine device in place or practice abstinence during the course of the study. Patients will be recruited from the epilepsy patient population at the National Institutes of Health. Subjects in groups A and B will be matched for seizure frequency. Volunteers will be matched with the subjects in group A by age. In this pilot study, no attempt will be made to match patients according to anticonvulsant medications. The patient will be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study. EXCLUSION CRITERIA: Any of the following conditions are cause for exclusion from the study: Any illness requiring chronic drug therapy other than antiepileptic drugs. Any history of an illness likely to be adversely affected by the trial. Psychiatric hospitalization lasting more than 2 months at any time prior to the study. Use of tricyclic antidepressants within 4 weeks prior to randomization and/or anti-psychotic drugs within 2 weeks prior to randomization. Children will not be included in this pilot study, because the profile of hormonal secretion undergoes profound changes during puberty. Use of illicit drugs, alcoholism or binge drinking as per medical history inventory. Women who are unwilling to use an alternative to oral contraceptives for contraception, (double barrier contraceptives, intrauterine device or abstinence), and establish that they are currently not pregnant by submitting to a pregnancy test. Exposure to any other investigational drug within 12 weeks prior to randomization. Any history of endocrine dysfunction. Women will be excluded if they do not have regular menstrual cycle intervals between 27 and 32 days or if they are pregnant, nursing or taking oral contraceptives or other reproductive hormones. If a need should arise to change the antiepileptic regime during the study this subject will be excluded and replaced with another patient. Women currently taking Phenobarbital or another barbiturate. Women who are unwilling to refrain from strenuous exercise during the study. Women who are unwilling to refrain from usage of herbal and soy products.