Epilepsy in infants poses significant challenges, often leading to difficulties in controlling seizures and impacting their neurological development. A phase 4 clinical trial investigated the potential of using a classic ketogenic diet as an alternative treatment method for infants with drug-resistant epilepsy. This article aims to present the findings of this trial, shedding light on its significance in managing epilepsy in infants.
Conducted in multiple hospitals across the UK, the trial enrolled infants aged 1–24 months who experienced drug-resistant epilepsy, characterized by frequent seizures despite trying two or more antiseizure medications. The study involved two groups: one received a classic ketogenic diet, and the other was given additional antiseizure medication, both for 8 weeks.
The primary aim of the trial was to measure the average number of seizures per day during weeks 6–8. Surprisingly, the trial results indicated that the ketogenic diet didn’t significantly reduce seizure frequency compared to providing additional antiseizure medication. Both groups showed similar median seizure rates during these weeks, with the ketogenic diet group experiencing an average of 5 seizures per day and the medication group facing around 3 seizures per day.
Safety and Tolerability
While the efficacy between the two treatments didn’t show a noticeable difference, the trial confirmed the safety of ketogenic diets for infants with drug-resistant epilepsy. Serious adverse events occurred at similar rates in both groups, with seizures being the most common event. However, the trial reported three unfortunate deaths, all occurring in infants assigned to the ketogenic diet group. Nevertheless, thorough investigations by local principal investigators and the data safety monitoring committee concluded that these deaths were unrelated to the treatment.