Repeat-Dose Pharmacokinetics Study of NRL-1 in Epilepsy Subjects

Phase 1 Completed 57 enrolled Neurelis, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

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 subject's body weight.

Timeline

Start: 2016-06-30
Primary completion: 2019-04-10
Completion: 2019-09-10

Publications

Background Hogan RE, Tarquinio D, Sperling MR, Klein P, Miller I, Segal EB, Rabinowicz AL, Carrazana E. Pharmacokinetics and safety of VALTOCO (NRL-1; diazepam nasal spray) in patients with epilepsy during seizure (ictal/peri-ictal) and nonseizure (interictal) conditions: A phase 1, open-label study. Epilepsia. 2020 May;61(5):935-943. doi: 10.1111/epi.16506. Epub 2020 Apr 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diazepam	Small molecule	5 mg	Intranasal
Subject	Diazepam	Small molecule	10 mg	Intranasal
Subject	Diazepam	Small molecule	15 mg	Intranasal
Subject	Diazepam	Small molecule	20 mg	Intranasal

Repeat-Dose Pharmacokinetics Study of NRL-1 in Epilepsy Subjects

Summary

Timeline

Publications

Drugs

Indications