Ignite Creation Date:
2024-05-06 @ 8:23 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02724423
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2016-03-17
Brief Title:
Repeat-Dose Pharmacokinetics Study of NRL-1 in Epilepsy Subjects
Sponsor:
Neurelis Inc
Organization:
Neurelis Inc
Study Overview
Official Title:
An Open-Label Repeat-Dose Pharmacokinetics Study of NRL-1 in Epilepsy Subjects Under Seizure and Normal Conditions
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the pharmacokinetic and safety of NRL-1 in epilepsy subjects Subjects will receive a single intranasal dose of NRL-1 of either 5 mg 10 mg 15 mg or 20 mg and will be based on the subjects body weight
Detailed Description:
Diazepam rectal gel Diastat is the only formulation of diazepam indicated for the management of selected refractory patients with epilepsy on stable regimens of antiepileptic drugs AEDs who require intermittent use of diazepam to control bouts of increased seizure activity ie Acute Repetitive Seizures ARS
A diazepam nasal spray is being developed for patients who experience ARS to provide an alternative more convenient and acceptable route of diazepam administration
A diazepam nasal spray is being developed for patients who experience ARS to provide an alternative more convenient and acceptable route of diazepam administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None