Conditions: Epilepsy
Keywords: Epilepsy Partial Onset Seizures Lacosamide Monotherapy Vimpat
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 426
Healthy volunteers: no

Brief summary:
The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Detailed description:
Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal relationship with the administration of antiepileptic drugs has not been established. The most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients with only GTCS were enrolled in the conversion to monotherapy study. In this study, two patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.

Arms:
arm 1: Lacosamide 400 mg/day arm 2: Lacosamide 300 mg/day

Interventions: intervention 1: Lacosamide intervention 2: Lacosamide
Intervention descriptions: intervention 1: 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. intervention 2: 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.

Protocol document: