Abstract
Epilepsy affects about 50 million people worldwide and around 30% of these patients have refractory epilepsy, with potential consequences regarding quality of life, morbidity and premature mortality. The aim of treatment with antiseizure medications (ASMs) is to allow patients to remain without seizures, with good tolerability. Levetiracetam is a broad-spectrum ASM with a unique mechanism of action that differs it from other ASMs. It has been shown to be effective and safe for treating adults and children with epilepsy. This was a phase III, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of levetiracetam in children and adults (4-65 years) as an adjuvant treatment for focal-onset seizures. It was conducted among 114 patients undergoing treatment with up to three ASMs. The primary efficacy analysis was based on the proportion of patients who achieved a reduction of ≥ 50% in the mean number of focal seizures per week, over a 16-week treatment period. The patients were randomized to receive placebo or levetiracetam, titrated every two weeks from 20 mg/kg/day or 1,000 mg/day up to 60 mg/kg/day or 3,000 mg/day. Levetiracetam was significantly superior to placebo (p = 0.0031); 38.7% of the participants in the levetiracetam group and 14.3% in the control group shows reductions in focal seizures. Levetiracetam was seen to have a favorable safety profile and an adverse event rate similar to that of placebo. Corroborating the results in the literature, levetiracetam was shown to be effective and safe for children and adults with refractory focal-onset epilepsy.
Highlights
Epilepsy is one of the most common neurological diseases and affects approximately 50 million people worldwide[1,2]
Around 30% of patients have refractory epilepsy[4], which is common in individuals with focal seizures[5]
Population This study included participants between 4 and 65 years old with refractory focal epilepsy, with or without focal to bilateral tonic-clonic seizure, as defined by the International League Against Epilepsy (ILAE)[8], They needed to have had this condition for at least two years, without any progressive or expansive brain injury previously documented, with a minimum of 12 seizures in the last 12 weeks before screening; and they needed to have been on a stable therapeutic regimen of up to three antiseizure medications (ASMs) for at least one month
Summary
Epilepsy is one of the most common neurological diseases and affects approximately 50 million people worldwide[1,2]. Individuals with epilepsy are more susceptible to physical trauma (such as fractures and bruises), psychiatric disorders (such as depression and anxiety) and premature death The risk that they face is up to three times higher than that of the general population[2]. Methods: This was a phase III, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of levetiracetam in children and adults (4–65 years) as an adjuvant treatment for focal-onset seizures. It was conducted among 114 patients undergoing treatment with up to three ASMs.The primary efficacy analysis was based on the proportion of patients who achieved a reduction of ≥ 50% in the mean number of focal seizures per week, over a 16-week treatment period. Conclusion: Corroborating the results in the literature, levetiracetam was shown to be effective and safe for children and adults with refractory focal-onset epilepsy
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