Conditions: Refractory Epilepsy
Keywords: Seizures Epilepsy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 78
Healthy volunteers: no

Brief summary:
This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1 comprises the subjects used to determine the relative bioavailability of DZNS versus DRG (Diastat)

Detailed description:
To determine the bioavailability of diazepam nasal spray versus diazepam rectal gel (Diastat®) under conditions of use in adolescent and adult persons with epilepsy (PWE) meeting the definition of refractory epilepsy.

Arms:
arm 1: One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device. arm 2: A single rectal dose of diazepam will be administered to subjects according to the Diastat prescribing information.

Interventions: intervention 1: diazepam nasal spray intervention 2: diazepam rectal gel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: