Albert P Aldenkamp1, Willem C J Alpherts. 1. Department of Behavioural Sciences Epilepsy Centre Kempenhaeghe, Heeze, the Netherlands. AldenkampB@kempenhaeghe.nl
Abstract
PURPOSE:Rufinamide (RUF 331; 1-(2,6-difluoro-phenyl)methyl-1H-1,2,3-triazole-4-carboxamide) is a structurally novel compound that limits the frequency of sodium-dependent neuronal action potentials. So far no data have been published on the cognitive effects of RUF, except for two animal studies. METHODS: The study used a multicenter, multinational double-blind, randomized, placebo-controlled parallel-study design with four different doses of RUF (based on prior studies): 200 mg/day, 400 mg/day, 800 mg/day, and 1,600 mg/day as add-on to the existing medication. All patients had partial seizures, in the age range of 15-64 years (with an average of 37.5 years). Cognitive assessments were performed at baseline (before the start with RUF treatment) and at end point (after 3 months of treatment). RESULTS: In total, 189 patients were included, divided over the treatment groups: placebo (n = 41), 200 mg/day (n = 33), 400 mg/day (n = 38), 800 mg/day (n = 37), and 1,600 mg/day (n = 40). The most important finding is that for none of the cognitive tests did a statistically significant worsening occur for any of the doses of RUF when the period after 12 weeks of treatment was compared with the baseline before introducing RUF. Also none of the comparisons between dose and placebo showed a statistically significant difference. CONCLUSIONS:RUF is a new AED with no serious cognitive effects even in add-on treatment and even in the higher dose ranges.
RCT Entities:
PURPOSE:Rufinamide (RUF 331; 1-(2,6-difluoro-phenyl)methyl-1H-1,2,3-triazole-4-carboxamide) is a structurally novel compound that limits the frequency of sodium-dependent neuronal action potentials. So far no data have been published on the cognitive effects of RUF, except for two animal studies. METHODS: The study used a multicenter, multinational double-blind, randomized, placebo-controlled parallel-study design with four different doses of RUF (based on prior studies): 200 mg/day, 400 mg/day, 800 mg/day, and 1,600 mg/day as add-on to the existing medication. All patients had partial seizures, in the age range of 15-64 years (with an average of 37.5 years). Cognitive assessments were performed at baseline (before the start with RUF treatment) and at end point (after 3 months of treatment). RESULTS: In total, 189 patients were included, divided over the treatment groups: placebo (n = 41), 200 mg/day (n = 33), 400 mg/day (n = 38), 800 mg/day (n = 37), and 1,600 mg/day (n = 40). The most important finding is that for none of the cognitive tests did a statistically significant worsening occur for any of the doses of RUF when the period after 12 weeks of treatment was compared with the baseline before introducing RUF. Also none of the comparisons between dose and placebo showed a statistically significant difference. CONCLUSIONS:RUF is a new AED with no serious cognitive effects even in add-on treatment and even in the higher dose ranges.