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.