According to Ovation, in previous studies, clobazam was shown to be well tolerated in patients with Lennox-Gastaut syndrome (LGS). The treatment met the primary endpoint in a Phase II dose-range finding study of a significant reduction in drop, or atonic, seizures compared to baseline. These seizures are the most debilitating of the LGS seizures types, which can result in severe trauma to the brain and body.
Joan Conry, professor of neurology and pediatrics in the department of neurology at the Children's National Medical Center in Washington, DC, said: “We know clobazam has an internationally well established safety and efficacy profile and if the results we have seen thus far are an indication of its potential in patients with LGS in the US, we may finally have a treatment that will fill an important unmet need.”
The Phase III study is designed to evaluate the safety and efficacy of clobazam in the reduction of atonic seizures at three dose levels in children and adults aged two to 60 years with LGS. The company plans to recruit patients with LGS at about 60 to 65 sites for the double-blind, placebo-controlled study that will last up to 23 weeks.
Ovation said that the latest study demonstrates its progress in advancing its central nervous system development pipeline.