Banzel Mobile Logo A Challenging Form of Epilepsy Seizure Types in LGS LGS Patient Profiles Pivotal Trial Design Efficacy of BANZEL® in Seizure Reduction Seizure Severity Rating Responder Rates Adverse Reactions Mechanism of Action/Pharmacokinetics Dosing

BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults.

Prescribing Information Important Safety Information For Patients

IMPACT OF BANZEL® ON SEIZURE SEVERITY RATING

IMPACT OF BANZEL® (rufinamide) 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

Shows the impact of BANZEL on the seizure severity rating. BANZEL showed significant improvement in the seizure severity rating in the pivotal trial. BANZEL patient experienced a 53.4% (N=39) improvement in the seizure severity scale of the global evaluation compared to 30.6% (N=19) of those on placebo. This was a primary efficacy endpoint. This assessment was based on a 7-point scale 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, espectively); Worsened: -3, -2, -1 (very much worse, much worse, minimally worse, respectively). Shows the impact of BANZEL on the seizure severity rating. BANZEL showed significant improvement in the seizure severity rating in the pivotal trial. BANZEL patient experienced a 53.4% (N=39) improvement in the seizure severity scale of the global evaluation compared to 30.6% (N=19) of those on placebo. This was a primary efficacy endpoint. This assessment was based on a 7-point scale 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, espectively); Worsened: -3, -2, -1 (very much worse, much worse, minimally worse, respectively).

*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.
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Plus icon Pivotal Trial Design Information
  • 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
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ADVERSE REACTIONS ►

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(adverse events)
profile of BANZEL®