Enrolling Now - 3
Neuralis: DIAZ.001.04
Study Title: An Open --Label, Repeat-Dose Pharmacokinetic Study of NRL-1 In Subjects Under Seizure and Normal Conditions
PI: Eric Segal, MD
KEY INCLUSION CRITERIA:
* Male and Female subjects between the ages of 6 and 65 years, inclusive
* Subject has a clinical diagnosis of Epilepsy and, is scheduled to be admitted to an EMU for extracranial video-EEG recording of a seizure event for evaluation of their Epilepsy and, in the opinion of the investigator, may need benzodiazepine intervention for seizure control
* Subjects having either partial or generalized Epilepsy with motor seizures or seizures with clear alteration of awareness are eligible for Enrollment
EXCLUSION CRITERIA
* A history of allergic or adverse responses to diazepam or any comparable or similar product.
* Treatment with Phenobarbital or primidone within 30 days of the anticipated dosing baseline visit.
* Treatment with any diazepam containing products within 14 days of the anticipated dosing visit.
* Use of nasal decongestants or nasal steroids within 7 days prior to the screening visit or during the study.
* Subject doesn't have the flu, rhinitis, or any other nasal condition that would impact absorption of nasal diazepam spray.
Enrollment is open for Pediatric age group only.