Rufinamide for the adjunctive treatment of partial seizures in adults and adolescents: A randomized placebo‐controlled trial

Abstract

SUMMARYPurpose: To evaluate efficacy and safety of adjunctive treatment with rufinamide 1600 mg twice daily in subjects aged ‡16 years with refractory partial seizures. Methods: This double-blind, placebo-controlled, randomized, parallel-group, multicenter trial included an 8-week baseline phase and a 13-week double-blind phase. Treatment was initiated with rufinamide 400 mg twice daily or placebo; rufinamide was titrated to 1600 mg twice daily. Percentage change in partial seizure frequency was the primary outcome measure. Secondary outcome measures included total partial seizure frequency and the percentage of subjects experiencing a ‡50% reduction in partial seizure frequency. Results: Three hundred thirteen subjects were randomized; 156 subjects received rufinamide and 157 received placebo. Rufinamide-treated subjects experienced a 20.4% median reduction in partial seizure frequency relative to baseline, while placebo-treated subjects had an increase of 1.6% (p = 0.02). Exclusion of subjects taking carbamazepine in a post hoc analysis resulted in a reduction of 29.2% versus 0.7% in the placebo group (p = 0.05), whereas the treatment difference in subjects taking carbamazepine was not significant. Of rufinamide-treated subjects, 28.2% experienced a ‡50% decrease in partial seizure frequency versus 18.6% of placebo-treated subjects (p = 0.04). The most common adverse events associated with rufinamide treatment were dizziness, nausea, diplopia, and ataxia; they occurred primarily during the titration phase. Discussion: Adjunctive therapy with rufinamide 3200 mg/day compared with matching placebo demonstrated efficacy and was generally well tolerated in adults with partial seizures. Further study of this agent in adults with partial seizures taking a range of baseline AEDs is warranted.

Rufinamide (Inovelon) in the Treatment of Lennox–gastaut Syndrome (A Review of Literature and Clinical Case)

“…В обзоре G. Coppola (2011) указывается, что пер-воначально эффективность и безопасность руфина-мида были доказаны в 3 рандомизированных контро-лируемых исследованиях: в дополнительной терапии фокальных приступов у взрослых и подростков (Brodie M. J. и соавт., 2009; Palhagen S. и соавт., 2001) и в ле-чении генерализованных приступов, ассоциирован-ных с СЛГ (Glauser T. и соавт., 2008) [13,15,16,29].…”

“…Умень-шение частоты приступов более чем на 50 % наблюда-ли у 28,2 % пациентов в группе руфинамида и у 18,6 % -в группе плацебо (p = 0,04). Отмечена хорошая переносимость руфинамида (наиболее рас-пространенные побочные эффекты включали голово-кружение, тошноту, диплопию и атаксию; наблюда-лись преимущественно в фазу титрации) [13].…”

Antiepileptic Drugs: Pharmacology, Epilepsy Indications, and Selection

“…Clinical trials showed modest efficacy in partial seizures in adults, and it is not approved for use in partial seizures at the present time. The most common adverse events associated with rufinamide are somnolence, dizziness, nausea, diplopia, and ataxia [83,84]. It is contraindicated for use in patients with the Short QT syndrome.…”

“…In a published trial of rufinamide in partial seizures, rufinamide was associated with a 20.4% median reduction in seizure frequency compared to a 1.6% increase in the placebo arm (p = 0.02) [84].…”

Rufinamid zur Kombinationstherapie fokaler Epilepsien

“…Nur 3 von 31 Patienten beklagten Nebenerscheinungen in Form einer Tagesmüdig-keit. Diese wird in der Produktinformation als sehr häufige Nebenwirkung (Häu-figkeit ≥1:10; [4]) angegeben und auch in allen anderen Studien als die häufigs-te beschriebene Nebenwirkung berichtet [3,8,9]. Bei 3 Patienten, alle mit einer schweren frühkindlichen Hirnschä-digung, wurde hingegen eine Verbesserung der Vigilanz berichtet.…”