Conditions: Epilepsy Partial Onset Seizures
Keywords: Levetiracetam Infusion Epilepsy Partial Onset Seizures
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: no

Brief summary:
To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as adjunctive treatment in subjects with Partial Onset Seizures after switching from the equivalent Levetiracetam oral dose.

Detailed description:

Arms:
arm 1: Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: * Formulation: concentrate for solution for infusion
* Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
* Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
* Frequency: twice daily

Protocol document: