Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy

A Phase IV, Open-label, Multi-center Trial to Evaluate the Safety and Efficacy of Keppra® After Conversion to Mono-therapy in Adult Subjects With Partial Epilepsy

A cohort of patients who became seizure-free during add-on treatment to one standard AED with Keppra in a previous trial (N01031) were followed to assess whether seizure freedom was maintained. Tolerability was documented.

Inclusion Criteria:

• Diagnosis of epilepsy with partial seizures;
• having completed the trial N01031 of Keppra as adjunctive therapy (SKATE);
• seizure-free over the last 3 months prior to protocol Visit 1;
• 1 concomitant marketed AED at the time of trial entry and throughout the previous trial N01031;
• on the clinical judgment of the Investigator, progressive withdrawal of the concomitant AED and conversion to monotherapy with Keppra can be attempted.

Exclusion Criteria:

• History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous 5 years;
• presence of known pseudoseizures within the last year;
• presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
• felbamate with less than 18 months exposure;
• vigabatrin, without visual field assessment as per recommendation of the manufacturer, i.e., every 6 months;
• uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.