OVATION REPORTS POSITIVE RESULTS FROM CATASTROPHIC EPILEPSY STUDY

Ovation Pharmaceuticals has announced positive results from its recent study to evaluate the safety and efficacy of clobazam in patients with Lennox-Gastaut syndrome (LGS), one of the most severe forms of childhood epilepsy. Clobazam has a unique chemical structure with associated properties when compared with other currently available benzodiazepines.

The Phase II, multicenter, randomized, double-blind, dose-finding study performed in the United States involved 68 patients (2 to 26 years of age) with LGS. Patients were randomized to two treatment groups with a low dose (target of 0.25 mg/kg/day) of clobazam or a high dose (target of 1.0 mg/kg/day) for a total treatment duration of up to 10 weeks.

Data from the trial showed both clinically relevant and statistically significant results. There was a significant difference between the treatment groups in the percent reduction in weekly drop seizures from baseline to maintenance period. Atonic or drop seizures are the most debilitating of the LGS seizure types and can result in severe trauma to the brain and limbs.

The data from the study show that the mean percent reduction in weekly drop seizures from baseline was 85.3 percent for the high-dose group and 12 percent for the low-dose group. More than 83 percent of patients from the high-dose group had a 50 percent or greater reduction in weekly drop seizures rate from baseline.

LGS, a form of catastrophic epilepsy characterized by several seizure types, occurs in 3 to 10 percent of all childhood epilepsies and onset typically occurs between the ages of 3 and 10, according to the company.