Ovation Begins Phase III Epilepsy Study With Clobazam

Ovation Pharmaceuticals announced the beginning of a pivotal Phase III clinical trial evaluating clobazam as an adjunctive treatment for patients with Lennox-Gastaut syndrome, a severe form of epilepsy.

The double-blind, placebo-controlled Phase III study will evaluate the safety and efficacy of clobazam at three dose levels in subjects between the ages of 2 to 60, Ovation said.

In previous studies, clobazam was well-tolerated and met the primary endpoint in a Phase II dose-finding study of a significant reduction in seizures compared with baseline, according to the company.

The company said it plans to recruit patients at approximately 60 to 65 sites. The study will last a maximum of 23 weeks.