Pediatrics Medical News about partial seizures;Rufinamide;adults and adolescents

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Rufinamide for the adjunctive treatment of partial seizures in adults and adolescents: A randomized placebo-controlled trial
Epilepsia, 06/05/09

Brodie MJ et al. – Adjunctive therapy with rufinamide 3200 mg/day vs matching placebo showed efficacy and was generally well tolerated in adults with partial seizures.

Methods

Study of efficacy and safety of adjunctive treatment with rufinamide 1600 mg twice daily in subjects age ≥16 yrs with refractory partial seizures
Double-blind, placebo-controlled, randomized, parallel-group, multicenter trial with 8-wk baseline phase and 13-wk double-blind phase
Treatment initiation with rufinamide 400 mg twice daily or placebo
Rufinamide titration to 1600 mg twice daily
Primary outcome measure: percentage change in partial seizure frequency
Secondary outcome measures: total partial seizure frequency and percentage of subjects with ≥50% reduction in partial seizure frequency

Results

Randomization of 313 subjects; 156 to rufinamide; 157 to placebo
Rufinamide-treated subjects had 20.4% median reduction in partial seizure frequency relative to baseline
Placebo-treated subjects had increase of 1.6%
Exclusion of carbamazepine subjects in post hoc analysis resulted in reduction of 29.2% vs 0.7% in placebo group
Treatment difference in carbamazepine subjects not significant
Of rufinamide-treated subjects, 28.2% had ≥50% decrease in partial seizure frequency vs 18.6% of placebo-treated subjects
Most common adverse events with rufinamide: dizziness, nausea, diplopia, ataxia; primarily during titration phase

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