Medecine effective in treating partial seizures

The use of investigational anticonvulsant rufinamide appears to reduce the risk of partial seizures by 50% in adults with inadequately controlled partial seizures, according to data presented here at the 58th Annual Meeting of the American Neurological Association (AAN).The results show that, compared with placebo, rufinamide achieved twice the reduction in partial seizures (18.6% vs 28.2%, respectively, P =.0381), the researchers reported.

Martin J. Brodie, MD, professor of medicine and clinical pharmacology, University of Glasgow, and clinical and research director, Epilepsy Unit, Western Infirmary, Glasgow, Scotland, led the double-blind, multicentre, placebo-controlled, randomised, parallel-group study.Researchers randomised 313 patients to a 56-day baseline phase and a 91-day double-blind treatment phase. During the treatment phase, rufinamide was titrated up to a dose of 3200 mg/day over 14 days.

Nearly 70.5% of patients on rufinamide were on 2 concomitant antiepileptic drugs (AEDs), and 29.5% on 1 concomitant AED.The primary efficacy measure of the study was to determine the change in partial seizure frequency relative to baseline. Secondary efficacy measures were total partial seizure frequency during the double-blind phase, the percentage of patients who experienced a > 50% reduction in partial seizure frequency every 28 days, and the change in secondarily generated seizures during a 28-day period.

Adverse events were also reported.The target dose was achieved in 68% of participants, with 82.1% achieving that dosage within the initial 7 days of the double-blind phase. No significant changes were reported in frequency of secondarily generalised seizure.Adverse events (AEs) reported in more than 10% of the study population included dizziness, headache, somnolence, nausea, fatigue, ataxia, vomiting, diplopia, viral infection, and abnormal vision.

Deaths occurred in 3 patients during the study, 2 in the rufinamide group and 1 in the placebo arm. However, none of the deaths were believed to be caused by rufinamide, according to the researchers.Severe adverse events occurred in 19.9% of the active treatment group, and 7.0% of the placebo arm, with the incidence of severe headache being the only noticeable difference between arms (5.8% in the rufinamide group, and 1.3% in the placebo arm).

Discontinuations due to adverse events occurred in 21 of 156 rufinamide-treated patients (13.5%) and 5 of the 157 placebo-treated patients (3.2%).