Lacosamide demonstrated significant control of partial-onset seizures with or without secondary generalization

Efficacy demonstrated in pooled analysis from
3 placebo‑controlled adjunctive‑therapy pivotal trials^1*

Seizure reduction with lacosamide vs placebo

Study Design: Age (mean): 40 years; Female 51%, Male 49%; Patients had a mean duration of epilepsy of 24 years; 45% of patients had tried 7 or more AEDs in their lifetime; 84% of patients were on 2 or 3 concomitant AEDs when lacosamide or placebo was added; Average median baseline seizure frequency was 11.5 seizures every 28 days.¹

*	Per 28 days from baseline to maintenance.
^†	P<0.05.
^‡	P<0.001.
	AED=anti-epileptic drug.

Lacosamide demonstrated consistent responder rates in partial-onset seizures

Significant efficacy demonstrated in the 400 mg/day dosage group¹

≥50% responder rates from baseline with lacosamide vs placebo

AED=anti-epileptic drug.

Lacosamide is proven to be effective as
monotherapy in partial-onset seizures

In a conversion to monotherapy study,* lacosamide
was statistically superior to a historical control group^2†

Kaplan-Meier predicted time to exit:
Patients meeting ≥1 exit criterion^‡

*	As per FDA monotherapy approval criteria.
^†	Lacosamide 300 mg/day also met the pre‑specified criteria for efficacy.
^‡	During the lacosamide maintenance phase. Exit criteria were 1 or more of the following: (1) doubling of average monthly seizure frequency during any 28 consecutive days; (2) doubling of highest consecutive 2-day seizure frequency; (3) occurrence of a single generalized tonic‑clonic seizure; (4) clinically significant prolongation or worsening of overall seizure duration, frequency, type, or pattern considered by the investigator to require trial discontinuation; (5) status epilepticus or new-onset serial/cluster seizures.

Study Design: To be included in Study 1, patients were required to be taking stable doses of 1 or 2 marketed antiepileptic drugs. This treatment continued into the 8-week baseline period. To remain in the study, patients were required to have at least 2 partial-onset seizures per 28 days during the 8-week baseline period. The baseline period was followed by a 3-week titration period, during which lacosamide was added to the ongoing antiepileptic regimen. This was followed by a 16‑week maintenance period (ie, a 6‑week withdrawal period for background antiepileptic drugs, followed by a 10-week monotherapy period). Patients were randomized 3 to 1 to receive lacosamide 400 mg/day or lacosamide 300 mg/day. Treatment assignments were blinded. Response to treatment was based on a comparison of the number of patients who met exit criteria during the maintenance phase, compared to historical controls. The historical control consisted of a pooled analysis of the control groups from 8 studies of similar design, which utilized a sub-therapeutic dose of an antiepileptic drug.²

*	As per FDA monotherapy approval criteria.
^†	Lacosamide 300 mg/day also met the pre-specified criteria for efficacy.
^‡	During the lacosamide maintenance phase. Exit criteria were 1 or more of the following: (1) doubling of average monthly seizure frequency during any 28 consecutive days; (2) doubling of highest consecutive 2-day seizure frequency; (3) occurrence of a single generalized tonic‑clonic seizure; (4) clinically significant prolongation or worsening of overall seizure duration, frequency, type, or pattern considered by the investigator to require trial discontinuation; (5) status epilepticus or new-onset serial/cluster seizures.

Lacosamide as adjunctive therapy demonstrated significant control of primary generalized tonic‑clonic seizure

In an adjunctive, multi-center study, significant efficacy in lowering risk of developing a second PGTC seizure³

Time to second PGTC seizure with lacosamide vs placebo in a 24‑hour period

Study Design: 24-week, double-blind, randomized, placebo-controlled, parallel-group, multi-center study. 12-week historical baseline period, 4-week prospective baseline period, and 24-week treatment period (which included a 6‑week titration period and an 18-week maintenance period). Eligible patients on a stable dose of 1 to 3 AEDs experiencing at least 3 documented PGTC seizures during the 16‑week combined baseline period were randomized 1:1 to receive lacosamide or placebo. Patients were dosed on a fixed-dose regimen, initiated at a dose of 100 mg/day in patients weighing ≥50 kg in 2 divided doses, titrated to achieve the target maintenance dose of 400 mg/day.³

P=0.001.
HR=0.548 (risk reduction=45.2%).
95% CI=[0.381, 0.788].

AED=anti-epileptic drug;
PGTC=primary generalized tonic‑clonic.