The new epilepsy medicine, cenobamate, has been found to be safe and effective in children with hard-to-treat focal-onset epilepsy, in line with study findings in adults with epilepsy. This is according to a piece of research from the US by Dr Robin Varughese and colleagues, published in the journal Epilepsy & Behavior.
The team set out to assess how safe and effective cenobamate is as an add-on treatment in children with hard-to-treat focal-onset seizures. They said this medicine is useful in adults but this has not yet been confirmed for children.
The study included 21 children, aged around 16 years old, on average. Cenobamate was introduced and the dose slowly increased as needed or up to a maximum of 400mg a day. On average, children weighing over 50kg needed around 200mg a day. In children weighing under 50kg, the average dose was 4mg a day for each kilo they weighed. The average reduction in seizure frequency was over half. Around three in five children (62.5%) had their seizures reduce by at least half. In over half of the children, seizures reduced by three-quarters, similar to the seizure reduction in adults. Just under one in five children (19%) became seizure free.
Of the 21 children, nine (42.8%) had side effects from cenobamate, which were usually problems with their balance or speech (ataxia) in about a quarter (23.8%) or sleepiness (sedation) in about one in 10 (9.5%). Three children dropped out of the study because of the side effects.
The researchers concluded that their findings show that cenobamate has similar effectiveness and safety in children as it does in adults, making it effective, safe and well-tolerated even at the maximum doses a day. However, larger studies are needed to confirm their results.
At the moment, cenobamate is only approved for use in adults. Doctors can only prescribe it for children on an unlicensed (off-label) basis. This means the doctor has to take individual responsibility for prescribing it. They will only do so if they are satisfied there is enough evidence it’s safe and effective, and that there are no approved medicines that would work instead.
The full study is available online.
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The National Institute for health and Care Excellence (NICE) has recommended the use of cenobamate for treating focal onset seizure in adults with hard-to-treat epilepsy on the NHS.