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

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.