Conditions: Epilepsy
Keywords: Lacosamide Vimpat Children Epilepsy Seizures Anti-epileptic
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 47
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to 3 other antiepileptic drugs (AEDs).

Detailed description:
Six subjects aged 5-11 (Cohort 1) were initially enrolled at the 8 mg/kg/day dose level. Upon completion of the study for these subjects, pharmacokinetic and safety data were analyzed to determine the target dose for the remaining subjects (either 8, 10 or 12 mg/kg/day). Depending on the selected target dose, four additional age-based cohorts of subjects were to be enrolled. LCM was increased 2 mg/kg/day per week until the target dose or maximum dose able to be tolerated was achieved.

Arms:
arm 1: Cohort 1 (Age 5 - 11 years); up to 8 mg/kg/day arm 2: Cohort 2 (Age 12 - 17 years); 12 mg/kg/day. arm 3: Cohort 3 (Age 2 - 4 years); 12 mg/kg/day. arm 4: Cohort 4 (Age 5 - 11 years); 12 mg/kg/day. arm 5: Cohort 5 (Age 1 month to \< 2 years); 12 mg/kg/day

Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL

Protocol document: