Conditions: Epilepsy Partial-onset Seizures
Keywords: Lacosamide LCM Epilepsy Partial-onset seizures iv
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

Brief summary:
EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.

Detailed description:

Arms:
arm 1: On Day - 1, LCM oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.

During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.

The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).

Interventions: intervention 1: Lacosamide (200 mg/20 mL)
Intervention descriptions: intervention 1: Active Substance: Lacosamide

Pharmaceutical form: Solution for intravenous (iv) infusion

Concentration: adapted on concentration of oral dose in EP0009

Route of Administration: Drip infusion

Protocol document: