Conditions: Epilepsy
Keywords: Cluster Seizures Seizures Clusters Acute repetitive seizures
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 126
Healthy volunteers: no

Brief summary:
This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).

Detailed description:

Arms:
arm 1: One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. arm 2: One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.

Interventions: intervention 1: diazepam nasal spray
Intervention descriptions: intervention 1: None

Protocol document: