trial comparing the efficacy and safety of lacosamide (lcm) to carbamazepine controlled-release (cbz-cr); initial monotherapy in epilepsy; subjects aged 16 and older

Conditions: Epilepsy; Monotherapy

Summary: compare efficacy and safety of lacosamide (lcm) to carbamazepine controlled-release (cbz-cr) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. noninferiority design to show a similar risk/benefit balance between lacosamide (lcm) and carbamazepine-cr (cbz-cr).


Eligibility criteria:
inclusion criteria: * subject able to comply with study requirements * subject is 16 years and older (female; male). minors will be included in countries only if legally permitted * subject has newly or recently diagnosed epilepsy experiencing partial onset seizures (pos) or generalized tonic-clonic seizures with at least 2 unprovoked seizures separated by 48 hours in the 12 months preceding visit 1 out of which at least 1 seizure occured 3 months preceding visit 1 * subject has had an electroencephalogram (eeg) and a brain computed tomography (ct) scan or magnetic resonance imaging (mri) exam of the brain within the past 12 months. if the eeg and brain ct scan or mri exam were not performed prior to visit 1, they need to be completed and results must be available prior to randomization at visit 2 exclusion criteria: * subject has a history or presence of seizures of other types than partial-onset (ia, ib, ic with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence) * subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, \< 20 minutes) with or without function regained between 2 ictal events * subject has a history, clinical, or electroencephalogram (eeg) finding suggestive of idiopathic generalized epilepsy (ige) at randomization * subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures based on expert opinion and/or eeg evidence * subject has any medical or psychiatric condition * subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (yes) to either question 4 or question 5 of the columbia-suicide severity rating scale (c-ssrs) at screening * subject has received treatment with phenobarbital or primidone within 28 days prior to visit 1 * subject is taking benzodiazepines for a nonepilepsy indication * subject has been treated for epilepsy with any antiepileptic drug (aed) (including benzodiazepines) in the last 6 months before visit. however, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 3 days prior to randomization * prior use of felbamate or vigabatrin is not allowed * benzodiazepines as rescue therapy for epilepsy may have been used as needed in this time period, but not more frequently than once per week * subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion, has a history of alcohol or drug abuse within the previous 2 years * asian ancestry and tests positive for hla-b\*1502 allele * asian ancestry and tests positive for hla-a\*3101 allele

Keywords: lacosamide vimpat® epilepsy monotherapy velocity