Clobazam Effective for Refractory Epilepsy in Children Younger Than 2

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Clobazam is currently FDA-approved for the treatment of seizures associated with Lennox-Gastaut syndrome in children 2 years and older.

WASHINGTON, DC – Clobazam is effective and well-tolerated in patients 2 years or younger with refractory epilepsy, according to data presented at the 2017 American Epilepsy Society Annual Meeting, December 1-5, 2017 in Washington, DC.

Clobazam is approved by the FDA as adjunctive therapy for the treatment of Lennox-Gastaut syndrome in patients 2 years or older; however there is little data available on the drug’s efficacy in younger patients.

Researchers conducted a retrospective review of patients at Boston Children’s Hospital from October 2011 to December 2016, and identified 155 patients aged ≤2 years who received clobazam. Of the 155 patients, 116 had full follow-up data at least 1 month after starting treatment and were included in the analysis.

At baseline, 27% of patients were taking 1 antiepileptic drug (AED), 45% were on 2 AEDs, and 22% were on 3 or more AEDs, while 6% received clobazam as monotherapy. Median starting dose was 0.42 mg/d, with increased of 2.5 mg/w to a titration target of 7.5 mg/d. The overall response rate was 33%, with a median seizure reduction of 75%. The researchers noted that 16% of patients had ≤50% reduction in seizures, 12% had no change in seizure frequency, and 14% experienced worsening of seizure frequency; however, 26% of patients became seizure-free. Seizure reduction occurred across multiple seizure types, including epileptic spasm, focal seizures, structural metabolic and unknown etiologies.

Overall, 7% of patients discontinued treatment: 4% due to adverse events, and 3% due to lack of efficacy. Common adverse effects were weakness, somnolence, and irritability, followed by drowsiness and dizziness, which were less common.

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Disclosures: The study was funded by Lundbeck.

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Buraniqi E, Wang X, Touserkani FM, Kapur K, Loddenkemper T. Efficacy and safety of clobazam in a pediatric refractory epilepsy population less than two years of age. Presented at: 2017 American Epilepsy Society Annual Meeting. December 1-5, 2017; Washington, DC. Abstract 2.180.