Oral Presentations

Objective: Many infancy-onset epilepsies are poorly responsive to anti-seizure medicines (ASMs) with poor prognosis for neurodevelopmental outcome.Ketogenic diets (KD) are high-fat, low-carbohydrate diets, shown to reduce seizures in older children and adults.No high-quality evidence is available for infants.Methods: Infants (age 1-24 months) with epilepsy, average ≥4 seizures/week and previous trial ≥2 ASMs, were randomised to receive a classical KD or further ASM.The primary outcome was difference in number of seizures during weeks 6-8 accounting for baseline.Results: Seventy-eight children were randomised to KD and 58 to ASM.The median number of daily seizures was similar in both groups at 8 weeks (IRR 1.33 95% CI 0.84, 2.11).The odds ratio of achieving ≥50% seizure reduction was 1.21 (95% CI 0.55, 2.65), and 0.88 (0.27, 2.80) for seizure freedom.A higher proportion of infants in the ASM group changed the number or dose of concurrent ASMs during the intervention period (24/48 [50%]) compared to KD (9/66 [14%]).Side effect score at 8 weeks was similar in both groups (KD median 40 IQR 38, 42; ASM median 41 IQR 39, 44).Overall health was numerically higher in the KD group (median 60 IQR 30, 60) at 8 weeks compared to ASM (median 30 IQR 30, 60).Communication (2.79 95% CI -8.14, 13.72) and socialisation (1.12 95% CI -17.13, 19.36) numerically improved in the KD group compared to ASM at 12 months.A similar proportion of infants in both groups reported at least one serious adverse event (43% ASM; 51% KD)-most commonly seizures.Conclusions: KD appears numerically similar in efficacy and tolerability to further ASM in infants with drugresistant epilepsy.The odds ratio of achieving seizure freedom at 8 weeks, and communication, socialisation and overall health scores numerically favoured KD compared to further ASM.