Abstracts

Rationale: Clobazam is a 1,5 benzodiazepine which has been available and used widely for treatment of seizures and anxiety in many countries other than the United States since the 1970 s. Recently, Phase III clinical trials sponsored by Lundbeck, Inc, studying the safety and efficacy of clobazam in patients with Lennox Gastaut Syndrome have demonstrated efficacy in reduction of drop as well as non-drop seizures. We report our experience with clobazam for treatment of medically refractory epilepsy in a much more diverse population of children and young adults. Methods: Between 2006 and 2010, 39 patients were prescribed clobazam for treatment of seizures under a CNMC IRB protocol titled The Use of Drugs Which are Not Available in the United States for the Treatment of Refractory Seizures and Refractory Movement Disorders . Clobazam was obtained by the parent/caregiver outside the United States, usually from Canada. Data regarding the patients, including dose of clobazam, seizure type, and dose limiting side effects was obtained via a retrospective chart review. Results: 25 patients were taking clobazam at the most recent office visit. 14 had discontinued the medication. Demographics and dosing of clobazam is summarized in the table . Only one patient has complete seizure control on clobazam monotherapy. Reason for discontinuation was hypotonia (1), irritability (1), encephalopathy (1), lack of efficacy without other unacceptable side effects (6), increased myoclonic seizures (1), increased pulmonary secretions (2), death not related to clobazam (2). 11 of 18 patients with drop seizures benefited enough that the medication was/is continued. No specific seizure type or etiology seemed either extremely sensitive to clobazam or refractory to the medication. Conclusions: Clobazam as adjunctive seizure therapy substantially improved seizure control in over 60% of this extremely medically refractory population of patients. The dose of clobazam which we used is similar to dosing in the Phase III trial. Dose limiting side effects occurred in only 15% and were side effects one would expect with this class of medications. Clobazam may contribute significantly to seizure control in children and young adults with medically refractory epilepsy.