IMPACT OF BANZEL® (rufinamide) ON SEIZURE
IMPACT OF BANZEL® ON SEIZURE SEVERITY RATING
Significant improvement in seizure severity was reported with BANZEL® in the pivotal trial*†‡
Seizure severity scale of the global evaluation*†‡1,2
*Based on parent/guardian global evaluation.
†Primary efficacy endpoint.
‡Based on a 7-point assessment performed by the parent/guardian at the end of the double-blind phase. Categories were: No change: 0; Improved: 1, 2, 3 (minimally improved, much improved, very much improved, respectively); Worsened: -3, -2, -1 (very much worse, much worse, minimally worse, respectively).
- References: 1. Glauser et al. Rufinamide for generalized seizures associated with Lennox-Gastaut syndrome. Neurology. 2008;70(21):1950-1958. 2. BANZEL® (rufinamide) prescribing information, Eisai Inc. 3. Data on file, Eisai Inc.
- A 12-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial to assess the effectiveness of BANZEL (rufinamide) to reduce inadequately controlled seizures associated with LGS in patients (N=138, intent to treat) being treated with 1-3 concomitant stable-dose AEDs1-3
- The primary efficacy variables were the percent change in total seizure frequency per 28 days, the percent change in tonic-atonic (drop attacks) seizure frequency per 28 days, and the seizure severity rating from the parent/guardian global evaluation of the patient's condition1
- All 3 primary endpoints met the prespecified statistical criteria for effectiveness1