Journal of Child Neurology
Safety and Local Tolerability of Diazepam Nasal Spray for Children With Epilepsy Aged 2-5 Years: Final Results of a Phase 1/2a Trial
Diazepam nasal spray is approved to treat seizure clusters in patients aged ≥2 years. A long-term safety study in patients aged 6-65 years found a safety profile similar to diazepam rectal gel. We conducted an open-label, phase 1/2a trial of diazepam nasal spray in children with epilepsy aged 2-5 years with motor seizures or seizures with clear alteration of awareness. After a pharmacokinetic period, caregivers were instructed to use diazepam nasal spray (0.5 mg/kg) as needed for frequent seizures or seizure cluste …