Epilepsy & behavior reports
Efficacy and safety of diazepam nasal spray in Japanese Pediatric patients with or at risk for status epilepticus: a phase 3, Multicenter, open-label clinical trial
By Nakagawa E, Tohyama J, Kira R and 9 others.
Abstract
Objective
To evaluate the efficacy and safety of diazepam nasal spray (tradename: SPYDIA in Japan, VALTOCO® in the US) following single (Part 1) and multiple (Part 2) dose administrations in pediatric epilepsy patients.
Methods
Patients aged 6-17 years with status epilepticus (SE) or at risk for progression to SE despite stable antiseizure medication were eligible. In Part 1, a single intranasal dose (5, 10, or 15 mg) was administered immediately after the onset of a prespecified convulsive seizure. The primary endpoint was the responder rate (seizures ceasing within 10 min post-dose without recurrence for 30 min) in this part. In Part 2, multiple doses were administered for up to 24 weeks to assess efficacy and safety.