evaluation of the efficacy and tolerability of vimpat when added to levetiracetam

Conditions: Epilepsy

Summary: the main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel blocking-antiepileptic drug (aeds) in subjects not well controlled on their current regimen.


Eligibility criteria:
inclusion criteria: * subject is male or female, at least 18 years of age * subject has a diagnosis of epilepsy with partial-onset seizures according to the international classification of epileptic seizures (1981) * subject is taking levetiracetam (lev) in combination with 1 sodium channel blocking antiepileptic drug (defined as carbamazepine, lamotrigine, oxcarbazepine, phenytoin, or eslicarbazepine) as adjunctive treatment for epilepsy * the minimum required seizure frequency during the 8-week retrospective seizure baseline is on average ≥ 2 partial-onset seizures per 28 days with at least 1 seizure per 4 week period within the 8-week retrospective seizure baseline. additionally, subjects must experience at least 1 seizure during the 4-week prospective seizure baseline * subject has been maintained on a stable dose of lev and a sodium channel blocking antiepileptic drug (scb-aed) for at least 4 weeks prior to the screening visit (visit 1) and during the 4-week prospective seizure baseline * the minimum required seizure frequency during the 8-week retrospective seizure baseline is on average ≥ 2 partial-onset seizures per 28 days (based on investigator assessment of subject report) with at least 1 seizure per 4 week period within the 8-week retrospective seizure baseline * subject has been maintained on a stable dose of levetiracetam (lev) and a sodium channel blocking antiepileptic drug (scb-aed) for at least 4 weeks prior to the screening visit (visit 1) and during the 4-week prospective seizure baseline, with or without additional concurrent stable vagal nerve stimulation (vns). the vns must have been in place for at least 6 months prior to the screening visit (visit 1) with constant settings for at least 4-weeks prior to the screening visit (visit 1) and throughout the duration of the study exclusion criteria: * previous use of lacosamide * history of alcohol or drug abuse * history of seizure disorder characterized primarily by isolated auras * history of primary generalized seizures * history of status epilepticus within the 12-months * history of clustering seizures * nonepileptic events, including pseudoseizures that could be confused with seizures * history of any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in this study * lifetime history of suicide attempt, or suicidal ideation in the past 6 months * hypersensitivity to any component of lacosamide (lcm) * history of acute or sub-acute progressive central nervous system disease * history of severe anaphylactic reaction or serious blood dyscrasias * impaired renal function (ie, creatinine clearance (clcr) is lower than 30 ml/min) at visit 1 * history of sick sinus syndrome without a pacemaker, or atrioventricular (av) block, or subject has any other clinically significant electrocardiogram (ecg) abnormalities * history sodium channelopathy, such as brugada syndrome * history of myocardial infarction in the last 3 months

Keywords: lacosamide epilepsy levetiracetam sodium channel blockers