The purpose of this study is to determine whether levetiracetam as adjunctive therapy is effective in the treatment of partial seizures, with or without secondary generalization, associated with refractory focal epilepsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
Oral solution (Each mL contains 100mg of levetiracetam) or immediate-release tablets (Tablets containing 500mg or 1000mg of levetiracetam)
Placebo, properly standardized to suit the characteristics of each dosage form (oral solution and tablets) of levetiracetam
Partial onset seizure frequency per week.
Collection of seizure count throughout the whole study
Time frame: From baseline to week 24
Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and ECG and laboratory tests results.
Collection of safety data throughout the whole study period
Time frame: From baseline to week 30
Proportions of response between the groups of treatment. (Responders defined as number of patients with at least 50% reduction in the number of weekly partial seizures)
Comparative between baseline and treatment periods
Time frame: From baseline to week 24
Percentage reduction from baseline in partial seizure frequency of days a week.
Comparative between baseline and treatment periods
Time frame: From baseline to week 24
Proportion of response between the groups of treatment. (Responders defined as number of subjects with at least 50% reduction in the number of days per week with partial seizures)
Comparative between baseline and treatment periods
Time frame: From baseline to week 24
Proportion between the groups of treatment without any kind of seizures. (seizure free)
During the evaluation period of treatment, without the titration period
Time frame: 12 weeks after the titration period (period with stable regimen of the drug)
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