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      Lacosamide Monotherapy Efficacious for Treatment of Partial-Onset Seizures

      By Brian Hoyle

      Washington, DC -- December 9, 2013 -- Lacosamide, which has already been approved for adjunctive use in patients with partial-onset seizures concomitantly medicated using anti-epileptic drug (AED) polytherapy, is safe and effective when used as the sole therapeutic drug, according to a study presented here at the 67th Annual Meeting of the American Epilepsy Society (AES).

      Robert T. Wechsler, MD, Idaho Comprehensive Epilepsy Center, Boise, Idaho, presented the results from a randomised, historical-controlled, double-blind trial on December 7.

      The trial, which was conducted in the United States, Canada, Europe, and Australia, comprised 425 patients with epilepsy (aged 16 to 70 years) who were on a stable physician-chosen regimen of 1 or 2 AEDs. Other inclusion criteria were diagnosis of epilepsy with partial-onset seizures, documented occurrence of 2 to 40 partial seizures in the baseline phase of the study, and a stable dose of 1 or 2 AEDs for 28 days before baseline and during the baseline phase. Exclusion criteria were a history of primary generalised seizures, status epilepticus in the preceding year, history of cluster seizures within 8 weeks of the start of the study, a seizure-free period of ?28 days during baseline, and >5 seizures of any type during the baseline phase.

      The objective was to evaluate the efficacy and safety of the conversion of therapy from AEDs to lacosamide monotherapy.

      Patients commenced an 8-week baseline phase, during which current therapy with AEDs was continued. The patients were then randomised 3:1 into a titration phase in which lacosamide was introduced at 200 mg/day and ramped up to 300 mg/day in the second week and either maintained there (n = 106) or increased during the third week to 400 mg/day (n = 319). Over the next 6 weeks, AEDs (most commonly levetiracetam, carbamazepine, and lamotrigine) were withdrawn, and lacosamide 300 or 400 mg/day was continued for another 10 weeks (total maintenance phase of 16 weeks). The 300-mg/day arm was included for blinding and consistency with the historical control studies. A 2-week taper or transition to open-label use was followed by a 2-week safety follow-up.

      The primary efficacy variable was the percentage of patients receiving lacosamide 400 mg/day who met ?1 of the following so-called exit criteria by day 112 of the maintenance phase: a ?2-fold increase in monthly frequency of partial-onset seizures compared with the seizure frequency during baseline; a ?2-fold increase in 2-day frequency of partial-onset seizures compared with 2-day periods during baseline; occurrence of tonic-clonic seizure if none had occurred in the 6 months preceding randomisation; persistence/worsening of overall seizure duration, frequency, type, or pattern serious enough for discontinuation of patient participation; and occurrence of status epilepticus or serial/cluster seizures.

      The baseline characteristics for both arms were comparable. The overall mean age was about 41 years and about half the population was male. The time since the initial diagnosis of epilepsy with partial seizures was approximately 17 years overall.

      Of the patients in the 300- and 400-mg/day arms, 99 and 284, respectively, completed the titration phase and were considered as the full analysis set. Of those patients, 70 and 201, respectively, completed the maintenance phase.

      One or more of the exit criteria comprising the primary efficacy variable were met by 28.9% of the patients in the lacosamide 400-mg/day arm. The Kaplan-Meier estimate of the percentage of patients meeting ?1 of the exit criteria in the lacosamide 400-mg/day arm (0.300; 95% confidence interval, 0.246-0.355) was statistically significantly lower than the historical control exit rate (0.653).

      The median duration of monotherapy was 71.0 22.0 days in the 300-mg/day arm and 71.0 20.3 days in the 400-mg/day arm. Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) assessments of percentage of patients showing improvement revealed the prowess of lacosamide at both 300 mg/day (CGIC, 72.7%; PGIC, 72.7%) and 400 mg/day (CGIC, 75.4%; PGIC, 74.3%).

      Treatment-emergent adverse events (TEAEs) were chronicled in 82.1% and 85.3% of patients receiving lacosamide 300 and 400 mg/day, respectively. There were no serious TEAEs in the 300-mg/day arm and 17 (5.3%) in the 400-mg/day arm. The most common TEAEs were dizziness, nausea, and headache.

      TEAEs caused discontinuation in 15.1% and 17.6% of patients in the 300- and 400-mg/day arms, respectively. The observed adverse events were similar to the historical safety and tolerability profiles of lacosamide.

      “This trial met its primary endpoint and showed that conversion to lacosamide monotherapy was statistically superior to the historical control, demonstrating that lacosamide 400 mg/day was effective as monotherapy in patients with partial-onset seizures,” concluded the researchers.

      Funding for the study was provided by UCB Pharma, Brussels, Belgium.
      <i></i><i>[Presentation title: Lacosamide Conversion to Monotherapy for the Treatment of Partial-Onset Seizures: Results From a Historical-Controlled, Multicenter, Double-Blind, Randomized Trial. Abstract 1.227]

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