This is a Phase 3, repeat dose, open-label, safety study in Epilepsy subjects who have frequent breakthrough seizures or ARS. NRL-1 will be administered as needed to treat bouts of those seizures over a 12-month period of time. Doses will be defined as 5 milligrams (mg), 10 mg, 15 mg, or 20 mg based on the subject’s body weight. A diary will be used to record the seizure and NRL-1 administration. The study consists of a screening phase, a baseline, a 12-month treatment period and a follow-up telephone contact 28-days after the last dose of NRL-1 or at study termination. The primary purpose of this study is to assess the safety of repeat doses of NRL-1 as intermittent chronic therapy to treat frequent break through seizures or ARS. Subjects will return to the site per the Schedule of Events with all study visits having a ±7 day window around visits.
Qualified participants for this study must be:
• male or female between 6 and 65 years, inclusive
• with clinical diagnosis of epilepsy and while on a stable regimen of anti-epileptic medication still experiences seizures
• with a qualified caregiver available to administer medication in the event of a seizure
• with no history of allergic or adverse responses to diazepam or any comparable or similar product.
If you’d like to enroll to this clinical trial, complete the form below and we’ll get back to you:
For more information, please call Estela Soniel at (973) 398 2900. You can also send an email to email@example.com.
ClinicalTrials.gov Identifier: NCT02721069