Pharmaceuticals, Inc. announced the initiation of a pivotal Phase III clinical trial evaluating clobazam, a unique 1,5 benzodiazapine with significant anticonvulsant properties, as adjunctive treatment for patients with Lennox-Gastaut syndrome (LGS), one of the most severe forms of childhood epilepsy that frequently persists into adulthood. In previous studies clobazam was shown to be well tolerated in patients with LGS and met the primary endpoint in a Phase II dose range finding study of a significant reduction in drop (or atonic) seizures compared to baseline. Drop seizures are the most debilitating of the LGS seizures types, which can result in severe trauma to the brain and body. This latest study demonstrates OVATION's progress in advancing its central nervous system (CNS) development pipeline.
"LGS, like many catastrophic epilepsies, can be both devastating and overwhelming for patients and their families, and clobazam may offer improved seizure control for patients affected by this condition," said Stephen D. Collins M.D., Ph.D., Chief Scientific Officer and Vice President of Clinical Affairs, Ovation Pharmaceuticals. "OVATION remains committed to exploring new treatment options for epilepsy, particularly where current treatment needs are not fully addressed."
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 (ages 2-60 years) with LGS. The company plans to recruit patients with LGS at approximately 60-65 sites. The double-blind, placebo-controlled study will last up to 23 weeks. For more information and study locations, please visit www.clinicaltrials.gov.
"LGS is one of the most severe forms of epilepsy and we desperately need new treatment options," said Eric R. Hargis, President and CEO of the Epilepsy Foundation. "We hope that the Phase III study shows great results and that clobazam brings new hope to the children and young adults who suffer from this devastating condition." "For this patient population, there is an urgent need for novel therapies that help manage the disease," said lead study investigator Joan A. Conry, M.D., Professor of Neurology and Pediatrics in the Department of Neurology at Children's National Medical Center in Washington, D.C. "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 U.S., we may finally have a treatment that will fill an important unmet need."
Clobazam is one of the key products in OVATION's CNS development program. The company is advancing its near-term pipeline on other fronts as well. In July 2007, the company initiated a clinical trial to evaluate a novel intravenous formulation of carbamazepine, a widely used oral antiepileptic drug, in adult patients with epilepsy. The launch of another oral anticonvulsant for rare and refractory epilepsies is anticipated next year.