A Cochrane review [Abstract] 1 included 6 studies with a total of 1759 subjects. Four trials (n=1563) included people with uncontrolled focal seizures and 2 trials (n=196) established Lennox-Gastaut syndrome. The age of the adults ranged from 18 to 80 years and the age of the children from 4 to 16 years. The overall RR for 50% or greater reduction in seizure frequency was 1.79 (95% CI 1.44 to 2.22; 6 RCTs, n=1759) indicating that rufinamide plus conventional AED was significantly more effective than placebo plus conventional AED in refractory focal epilepsy. The overall RR for treatment withdrawal (for any reason and due to AED) was 1.83 (95% CI 1.45 to 2.31; 6 RCTs, n=1759) showing that rufinamide was significantly more likely to be withdrawn than placebo. The adverse events significantly associated with rufinamide were headache, dizziness, somnolence, vomiting, nausea, fatigue and diplopia.
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