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The effectiveness of KEPPRA as adjunctive therapyadded to other antiepileptic drugsin adults was established in three multicenterrandomizeddouble-blindplacebo-controlled clinical studies in patients who had refractory partial onset seizures with or without secondary generalizationThe tablet formulation was used in all these studiesIn these studies904 patients were randomized to placebo1000 mg2000 mgor 3000 mg/dayPatients enrolled in Study 1 or Study 2 had refractory partial onset seizures for at least two years and had taken two or more classical AEDsPatients enrolled in Study 3 had refractory partial onset seizures for at least 1 year and had taken one classical AEDAt the time of the studypatients were taking a stable dose regimen of at least one and could take a maximum of two AEDsDuring the baseline periodpatients had to have experienced at least two partial onset seizures during each 4-week period.

In controlled trials of adult patients with epilepsy experiencing partial onset seizures15of KEPPRA-treated patients reported somnolencecompared to 8of placebo-treated patientsThere was no clear dose response up to 3000 mg/dayIn a study where there was no titrationabout 45of patients receiving 4000 mg/day reported somnolenceThe somnolence was considered serious in 0.3of KEPPRA-treated patientscompared to 0in the placebo groupAbout 3of KEPPRA-treated patients discontinued treatment due to somnolencecompared to 0.7of placebotreated patientsIn 1.4of KEPPRA-treated patients and 0.9of placebo-treated patientsthe dose was reducedwhile 0.3of the KEPPRA-treated patients were hospitalized due to somnolence.

Table 3Adverse Reactions in Pooled Placebo-ControlledAdd-On Studies in Adults Experiencing Partial Onset Seizures.

The European Commission granted a marketing authorisation valid throughout the European Union for Keppra on 29 September 2000.

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