What is the role of rufinamide (Banzel) in the treatment of Lennox-Gastaut syndrome (LGS)?

Updated: Nov 09, 2018
  • Author: Koshi A Cherian, MD; Chief Editor: Amy Kao, MD  more...
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Answer

The FDA approved rufinamide (Banzel) in 2008 for the adjunctive treatment of seizures associated with LGS in children 4 years and older and adults. In a double-blind, randomized, placebo-controlled trial by Glauser et al, rufinamide produced a statistically significant decrease in total seizure frequency and tonic-atonic seizures in individuals aged 4-30 years. [22] A 2009 open-label European study also demonstrated decreased seizure frequency amongst those with LGS. [23]

In a multicenter clinical trial of 59 patients with LGS, rufinamide was found to decrease the frequency of tonic-atonic seizures by 24.2%, versus 3.3% with placebo, and total seizures by 32.9%, versus 3.3% with placebo. Adverse events in the rufinamide group included decreased appetite (17.2%), somnolence (17.2%), and vomiting (13.8%). [30]

In February 2015, rufinamide was approved in pediatric patients aged 1 to 4 years based on a pharmacokinetic bridging study of a Phase III clinical trial which demonstrated the pharmacokinetic and safety profiles are consistent with those seen in ages ≥ 4 years. [31]


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