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

BANZEL® DEMONSTRATED POWERFUL, BROAD SPECTRUM EFFICACY IN THE REDUCTION OF TOTAL SEIZURES

Median percent reduction in total seizure
frequency per 28 days relative to baseline*1,2

BANZEL (rufinamide) Efficacy Chart showing the median percent reduction in total seizure frequency per 28 days relative to baseline. BANZEL showed a 32.7% reduction in the number of total seizures (per 28 days relative to baseline) versus 11.7% reduction in the placebo group. This showed a statistical significance of P<0.002. The median percent reduction in total seizure frequency per 28 days relative to baseline was a primary efficacy endpoint of the pivotal trial. BANZEL (rufinamide) Efficacy Chart showing the median percent reduction in total seizure frequency per 28 days relative to baseline. BANZEL showed a 32.7% reduction in the number of total seizures (per 28 days relative to baseline) versus 11.7% reduction in the placebo group. This showed a statistical significance of P<0.002. The median percent reduction in total seizure frequency per 28 days relative to baseline was a primary efficacy endpoint of the pivotal trial. Seizure types in the trial population Seizure types in the trial population

*Primary efficacy endpoint.

Plus icon Seizure Types in the Trial Population

Percentage of trial patients with specific seizures at baseline1,3

Shows the percentage of BANZEL trial patient with specific seizures at baseline. There were 99% of BANZEL patients that experienced tonic –atonic seizures compared to 94% of placebo patients; 80% of BANZEL patients vs 86% placebo for atypical absence; 70% of BANZEL patients vs 67% experienced tonic seizures; 61% of BANZEL patients vs 52% of placebo patients experienced atonic seizures; 50% of BANZEL patients versus 48% of placebo patients experienced myoclonic seizures; 50% of BANZEL patients vs 42% of placebo patients experienced tonic-clonic seizures; 16% of BANZEL patients experienced unclassified seizures compared to 20% of placebo patients; 15% of BANZEL patients experienced partial seizures compared to 14% of placebo patients; 11% of BANZEL patients experienced absence seizures compared to 8% of placebo patients; and 9% of BANZEL patients experienced clonic seizures compared to 2% of placebo patients.

Adjunctive treatment with BANZEL® achieved a nearly three-fold median percent reduction in total seizures vs placebo

  • 32.7% and 11.7% for BANZEL and placebo, respectively (P<0.002)
  • Results vs placebo were statistically significant

Powerful efficacy in the reduction of tonic-atonic seizures (drop attacks)

Median percent reduction in tonic-atonic seizure frequency per 28 days relative to baseline*1,2

BANZEL (rufinamide) Efficacy Chart showing the median percent reduction in tonic-atonic seizure frequency per 28 days relative to baseline. BANZEL showed a 42.5% reduction in drop attacks in the BANZEL group vs a 1.4% increase in the placebo group (P<0.0001). This was a primary efficacy endpoint in the pivotal trial. BANZEL (rufinamide) Efficacy Chart showing the median percent reduction in tonic-atonic seizure frequency per 28 days relative to baseline. BANZEL showed a 42.5% reduction in drop attacks in the BANZEL group vs a 1.4% increase in the placebo group (P<0.0001). This was a primary efficacy endpoint in the pivotal trial.

*Primary efficacy endpoint.

A 42.5% reduction in drop attacks in the BANZEL® group vs a 1.4% increase in the placebo group (P<0.0001)

  • A primary efficacy endpoint, defined as percent change in the frequency of tonic-atonic (the sum of tonic and atonic seizures) per 28 days during the double-blind treatment phase
  • Results vs placebo were statistically significant
  • 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.
◄Previous Next: SEIZURE SEVERITY RATING►

Percentage of trial patients with specific seizures at baseline1,3

Shows the percentage of BANZEL trial patient with specific seizures at baseline. There were 99% of BANZEL patients that experienced tonic –atonic seizures compared to 94% of placebo patients; 80% of BANZEL patients vs 86% placebo for atypical absence; 70% of BANZEL patients vs 67% experienced tonic seizures; 61% of BANZEL patients vs 52% of placebo patients experienced atonic seizures; 50% of BANZEL patients versus 48% of placebo patients experienced myoclonic seizures; 50% of BANZEL patients vs 42% of placebo patients experienced tonic-clonic seizures; 16% of BANZEL patients experienced unclassified seizures compared to 20% of placebo patients; 15% of BANZEL patients experienced partial seizures compared to 14% of placebo patients; 11% of BANZEL patients experienced absence seizures compared to 8% of placebo patients; and 9% of BANZEL patients experienced clonic seizures compared to 2% of placebo patients.
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
Adverse Reaction icon

ADVERSE REACTIONS ►

See the safety
(adverse events)
profile of BANZEL®