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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.
Disclosures: The study was funded by Lundbeck.
For more coverage of AES 2017, click here.
Reference
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.
