TRIAL PATIENTS HAD HISTORY OF MULTIPLE SEIZURE TYPES, UNCONTROLLED ON 1-3 AEDs1-3
Trial design1,3
![BANZEL trial patients had a history of multiple seizure types and were uncontrolled on 1-3 AEDs. The prospective baseline was assessed at 28 days (n=139). At randomization 74 patients took BANZEL (who were on 1-3 AEDs) and 64 patients took placebo (who also was on 1-3 AEDs). Both of these patient groups were titrated for 14 days then placed on a maintenance dose for 70 days. After 12 weeks, the open-label extension portion of the trial began with 124 BANZEL patients. The open-label extension period lasted 3 years beginning with a 2-week double-blind conversion phase.](/~/media/Project/EIsai/BanzelHCP/Banzel-HCP/chart.png)
![BANZEL trial patients had a history of multiple seizure types and were uncontrolled on 1-3 AEDs. The prospective baseline was assessed at 28 days (n=139). At randomization 74 patients took BANZEL (who were on 1-3 AEDs) and 64 patients took placebo (who also was on 1-3 AEDs). Both of these patient groups were titrated for 14 days then placed on a maintenance dose for 70 days. After 12 weeks, the open-label extension portion of the trial began with 124 BANZEL patients. The open-label extension period lasted 3 years beginning with a 2-week double-blind conversion phase.](/~/media/Project/EIsai/BanzelHCP/Banzel-HCP/char_mobile.png)
*Approximately 3 years beginning with a 2-week, double-blind conversion phase.
- 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
BANZEL® trial population: key inclusion criteria†1,3
![Image of ≥90 in bold large lettering. This shows an aspect of the BANZEL trial population key inclusion criteria which included those patients who experienced ≥90 seizures in the month prior to baseline.](/~/media/Project/EIsai/BanzelHCP/Banzel-HCP/inter_chart_1.png)
seizures in month prior to baseline
![graphical interpretation of multiple seizure types. The BANZEL trial population included those patients with a history of multiple seizure types. This was a key inclusion criteria for the study.](/~/media/Project/EIsai/BanzelHCP/Banzel-HCP/inter_chart_2.png)
History of multiple seizure types
![icon of a person. The BANZEL trial population included those patients with a history of tonic-atonic and atypical absence seizures. This was a key inclusion criteria for the study.](/~/media/Project/EIsai/BanzelHCP/Banzel-HCP/inter_chart_3.png)
History of tonic-atonic and atypical absence seizures
![icons of a pill and tablet which represent a key inclusion criteria of the BANZEL clinical trial which included those patients who were inadequately controlled with 1-3 AEDs.](/~/media/Project/EIsai/BanzelHCP/Banzel-HCP/inter_chart_4.png)
Inadequately controlled with 1-3 AEDs
†Presents a partial list of criteria; there were additional inclusion and exclusion criteria in the pivotal trial.
Median number of total seizures in the 2 treatment groups during the 28-day baseline phase1:
BANZEL ® pivotal trial entry criteria
Patients in the BANZEL trial were subject to the following entry criteria ‡
INCLUSION
EXCLUSION
INCLUSION
EXCLUSION
‡This is not the complete list of inclusion/exclusion criteria.
-
Baseline characteristics of BANZEL study participants were similar
between study groups (BANZEL vs placebo):
- Gender ( 62.2% male vs 62.5% male), median age (13 years vs 10.5 years), median duration of LGS (8 years vs 8 years), and median weight (36 kg vs 34 kg)
Multiple seizure types observed at baseline
≥50% of BANZEL patients presented with tonic-atonic, atypical absence, tonic, atonic, myoclonic, and/or tonic-clonic seizures
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 siezures 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.](/~/media/Project/EIsai/BanzelHCP/Banzel-HCP/chart_1.png)
![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 siezures 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.](/~/media/Project/EIsai/BanzelHCP/Banzel-HCP/chart_1_mobile.png)
BANZEL® was studied as adjunctive treatment with a range of AEDs
Concomitant AEDs in the BANZEL® clinical trial
![Shows that BANZEL was studied as an adjunctive treatment with a range of AEDs. This chart shows a list of concomitant AEDs in the BANZEL clinical trial. Concomitant AEDs were used by at least 10% of patients included: valproate, lamotrigine, topiramate, clonazepam, carbamazepine, clobazam, phenytoin and phenobarbital. Percentage of concomitant use was as follows: Valproate was used by 60% of the BANZEL patients compared to 55% of those on placebo. Lamotrigine was used by 41% of BANZEL patients compared to 30% of those on placebo. Topiramate was used by 27% of BANZEL and placebo patients. Clonazepam was used by 19% of BANZEL patients and 11% of placebo patients. Carbamazepine was used by 16% of BANZEL patients compared to 19% of placebo patients. lobazam was used by 14% of BANZEL patients compared to 13% of placebo patients. Phenytoin was used by 14% of BANZEL patients compared to 19% of placebo patients. Phenobarbital was used by 8% of BANZEL patients compared to 14% of placebo patients.](/~/media/Project/EIsai/BanzelHCP/Banzel-HCP/chart_2.png)
![Shows that BANZEL was studied as an adjunctive treatment with a range of AEDs. This chart shows a list of concomitant AEDs in the BANZEL clinical trial. Concomitant AEDs were used by at least 10% of patients included: valproate, lamotrigine, topiramate, clonazepam, carbamazepine, clobazam, phenytoin and phenobarbital. Percentage of concomitant use was as follows: Valproate was used by 60% of the BANZEL patients compared to 55% of those on placebo. Lamotrigine was used by 41% of BANZEL patients compared to 30% of those on placebo. Topiramate was used by 27% of BANZEL and placebo patients. Clonazepam was used by 19% of BANZEL patients and 11% of placebo patients. Carbamazepine was used by 16% of BANZEL patients compared to 19% of placebo patients. lobazam was used by 14% of BANZEL patients compared to 13% of placebo patients. Phenytoin was used by 14% of BANZEL patients compared to 19% of placebo patients. Phenobarbital was used by 8% of BANZEL patients compared to 14% of placebo patients.](/~/media/Project/EIsai/BanzelHCP/Banzel-HCP/chart_2_mobile.png)
- 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.