Enrolling Now - 4
Neuralis: DIAZ.001.05
Study Title: A 12 Month, Open-Label, Repeat-Dose Safety Study of NRL-1 In Epilepsy Subjects.
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 while on a stable dose of anti-epileptic medications, still experiences bouts of seizures and who, in the opinion of Investigator may need benzodiazepine intervention for seizure control at least 1 time a month on average.
* Subjects having either partial or generalized Epilepsy with motor seizures or seizures with clear alteration of awareness are eligible for Enrollment
* Subject has a qualified caregiver or medical professional available that can administer study medication in the event of a seizure.
KEY EXCLUSION CRITERIA
* A history of allergic or adverse responses to diazepam or any comparable or similar product.
* Subject has had significant traumatic injury, major surgery or open biopsy within 30 days of enrollment
* Subject with active major depression or a past suicidal attempt or having active suicidal thoughts
Enrollment is open for Pediatric age group only.