Data Show Rufinamide, an Investigational Adjunctive Treatment for Lennox- Gastaut Syndrome, Reduced Drop Attacks by Mor...( Placebo-Controlled Study Results Pu...),Health

Placebo-Controlled Study Results Published in May 20 Issue of Neurology

WOODCLIFF LAKE, N.J., May 20 /PRNewswire/ -- Eisai Corporation of North America announced today the publication of a placebo-controlled study in Neurology that found patients with Lennox-Gastaut syndrome (LGS) treated with the investigational antiepileptic agent rufinamide as adjunctive therapy experienced more than 40% fewer drop attacks than patients who received placebo (increase of 1.4%). The differences between rufinamide and placebo were observed as early as week two of the study. LGS is a severe form of generalized epilepsy that develops in early childhood and is characterized by multiple types of treatment-resistant seizures and high rates of seizure-related injury.

"Lennox-Gastaut syndrome is a devastating form of pediatric epilepsy usually resulting in multiple seizures occurring several times a day and is often associated with impaired mental development," said the study's lead author Tracy Glauser, MD, Director, Comprehensive Epilepsy Program, Cincinnati Children's Hospital Medical Center, Ohio. "Existing antiepileptics offer limited seizure control and there may be difficulties with tolerability."

Study Methods

The study was a multicenter, double-blind, placebo-controlled, randomized, parallel-group study. Male and female patients (between 4 and 30 years of age) were included if they had a diagnosis of inadequately controlled seizures associated with LGS (including both atypical absence seizures and drop attacks) and were being treated with 1 to 3 concomitant stable dose antiepileptic drugs (AEDs). Each patient must have had at least 90 seizures in the 28-day baseline period prior to study entry. One hundred thirty-nine eligible patients were randomized; 138 patients received either rufinamide (titrated up to 45mg/kg per day) (n=74) or placebo (n=64) in addition to their other AEDs.

The median percentage reduction in total seizure frequency fr
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