Study on Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Female Subjects With C1 Catamenial Epilepsy

Inclusion Criteria: * Non-pregnant and non-nursing females between the ages of 18 - 45 years of age; * out-patients with epilepsy experiencing uncontrolled simple and/or complex partial seizures with or without secondary generalization for a minimum of 2 years; * classifiable epilepsy according to the International Classification of Epileptic Seizures; * minimum of 2 seizures per 4 weeks during the Baseline Period, without exceeding 100 seizures per 4 weeks. The majority of seizures (\>50%) must be partial onset, with or without secondary generalization; * exhibited, during the Baseline Period, a catamenial epilepsy type C1 pattern defined as at least a 70% increase of weekly seizure frequency during the menstrual phase compared to the luteal and follicular phases combined; * concurrent C2 catamenial epilepsy, defined as a 70% increase in daily seizure average during the ovulatory phase in comparison to the follicular and luteal phases combined, was permitted; * taking a minimum of one and a maximum of two antiepileptic drugs at a stable dose for a period of 4 weeks prior to the selection visit and during the duration of the trial; * vagal nerve stimulator (VNS) was permitted. Exclusion Criteria: * using felbatol and presented clinically significant abnormalities with WBCs, RBCs, platelets, and/or hepatic function during felbatol treatment, and taking felbatol less than one year from the date of the Selection Visit; * partial onset seizures uncountable due to clustering during the last 3 months; * hormonal contraceptives that block menses within 6 months of the selection visit with no washout period permitted; * menstrual cycle length less than 21 days and greater than 35 days during the baseline evaluation; * alternative medications documented or purported to impact reproductive hormone levels, within the prior 2 months with no washout period permitted; * significantly irregular menstrual cycles or a history of frequent amenorrhea defined as two episodes within the preceding 6 months; * not taking hormonal contraceptives with more than one anovulatory cycle during the Baseline Period; * clinically significant medical condition requiring treatment, except for the study indication, which would prevent clear interpretation of the study results; * using the following classes of medications influencing the central nervous system: antipsychotics (typical and atypical), psychostimulants (except those containing methylphenidate, dextroamphetamine, or amphetamine used in the treatment of Attention Deficit Disorder), and hypnotics; * chronically dosing with benzodiazepines; * hospitalized for depression within 3 months prior to the selection visit. * history of attempting suicide within the last 3 years, or suicidal ideation within the last 3 months; * recent history (within the past two years) or presence of significant alcohol abuse or drug abuse; * clinical history of significantly impaired renal function with a estimate of creatinine clearance below 80 ml/min; * history of clinically significant cardiac conditions; * ALT/SGPT, AST/SGOT, alkaline phosphatase, or ?-GT value of more than 3 times the upper limit of the central laboratory reference value; * presence of a terminal illness; * presence of any clinically significant allergic condition to levetiracetam or pyrrolidone derivatives; * neutrophil count of less than 1800 per ?L.