Abstracts

Rationale: Clobazam, a 1,5-benzodiazepine, is an antiepileptic drug (AED) that has been approved in more than 100 countries worldwide. The United States Food and Drug Administration (FDA) approved clobazam in October 2011 as an adjunctive therapy for Lennox-Gastaut syndrome (LGS). Previous studies have provided evidence that Clobazam is efficacious for both focal and generalized pediatric epilepsy. The purpose of the study is to examine the clinical experience with clobazam in refractory epilepsy at a large pediatric institution. Methods: After obtaining institutional IRB approval, a retrospective analysis was performed of 200 patients at Texas Children's Hospital who were treated with clobazam for refractory epilepsy from 2008 to 2013. Of the 200 reviewed, 167 patients yielded complete data sets and were included in the final analysis. All patients included in final analysis had clinical follow up to assess efficacy at least 3 months after starting clobazam and lasting up to one year. Data points included age, gender, ethnicity, epilepsy, and seizure type classified by ILAE criteria, history of antiepileptic drug (AED) treatment, doses prescribed of clobazam, and number of seizures per week during/after clobazam treatment. Results: Of the 167 patients who took clobazam, 54 (32%) had focal epilepsy, 82 (49%) had generalized epilepsy, and 31 (19%) had an unclassified type of epilepsy. At the time of beginning clobazam therapy, patients had previously failed an average of 3 AEDs and were on at least 2 other AEDs while on clobazam therapy. The median (interquartile range) amount of seizures per week reported before the initiation of clobazam was 28 (7.5-95.5). Patients were taking on average 15 mg of clobazam per day with a range from 3 to 50 mg. After patients started taking clobazam, the median (interquartile range) of seizures reported was 10 (0.44-33.25). 132 (79%) patients had a decrease in seizure frequency while 25 (15%) patients had no change and 10 (6%) patients had an increase in seizure frequency. 87 (52%) patients had a >50% reduction in seizures following administration of clobazam. 34 (20%) patients reported being completely seizure free. Conclusions: Our experience suggests that Clobazam may have broad-spectrum efficacy for many types of refractory pediatric epilepsy, beyond its current FDA approved indication of LGS.