Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects

Acute Repetitive Seizures Clinical Trial

Official title: A 12-Month Open-Label, Repeat-Dose Safety Study of NRL-1 in Epilepsy Subjects (DIAZ.001.05)

Status Completed

Clinical Trial Summary

This is a 12 month safety study to evaluate the safety of repeated doses of NRL-1

Clinical Trial Description

This is a Phase 3, repeat dose, open-label, safety study in Epilepsy subjects who have frequent breakthrough seizures or Acute Repetitive Seizures (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 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. ;

Related Conditions & MeSH terms

• Acute Repetitive Seizures
• Breakthrough Seizures
• Epilepsy
• Seizures

• NCT number: NCT02721069
• Study type: Interventional
• Source: Neurelis, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: April 11, 2016
• Completion date: July 23, 2020