Clinical Trials

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


* 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


* 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.