Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects

Summary

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

Timeline

Start

2016-04-11

Primary completion

2020-06-17

Completion

2020-07-23

Publications

• Tarquinio D, Wheless JW, Segal EB, Rabinowicz AL, Carrazana E. Safety and effectiveness of diazepam nasal spray in patients with Rett syndrome and seizure clusters: post hoc analyses from a long-term safety study and survey of severity and burden. Front Neurol. 2026 Feb 23;17:1702423. doi: 10.3389/fneur.2026.1702423. eCollection 2026.
• Misra SN, Jarrar R, Stern JM, Becker DA, Carrazana E, Rabinowicz AL. Rapid Rescue Treatment with Diazepam Nasal Spray Leads to Faster Seizure Cluster Termination in Epilepsy: An Exploratory Post Hoc Cohort Analysis. Neurol Ther. 2024 Feb;13(1):221-231. doi: 10.1007/s40120-023-00568-4. Epub 2024 Jan 4.
• Tarquinio D, Wheless JW, Segal EB, Misra SN, Rabinowicz AL, Carrazana E. Safety of Diazepam Nasal Spray in Pediatric Patients With Developmental Epileptic Encephalopathies: Results From a Long-term Phase 3 Safety Study. J Child Neurol. 2023 May;38(6-7):389-393. doi: 10.1177/08830738231185424. Epub 2023 Jul 16.
• Cramer JA, Faught E, Davis C, Misra SN, Carrazana E, Rabinowicz AL. Quality-of-life results in adults with epilepsy using diazepam nasal spray for seizure clusters from a long-term, open-label safety study. Epilepsy Behav. 2022 Sep;134:108811. doi: 10.1016/j.yebeh.2022.108811. Epub 2022 Jul 8.
• Wheless JW, Miller I, Hogan RE, Dlugos D, Biton V, Cascino GD, Sperling MR, Liow K, Vazquez B, Segal EB, Tarquinio D, Mauney W, Desai J, Rabinowicz AL, Carrazana E; DIAZ.001.05 Study Group. Final results from a Phase 3, long-term, open-label, repeat-dose safety study of diazepam nasal spray for seizure clusters in patients with epilepsy. Epilepsia. 2021 Oct;62(10):2485-2495. doi: 10.1111/epi.17041. Epub 2021 Aug 21.
• Miller I, Wheless JW, Hogan RE, Dlugos D, Biton V, Cascino GD, Sperling MR, Liow K, Vazquez B, Segal EB, Tarquinio D, Mauney W, Desai J, Rabinowicz AL, Carrazana E; DIAZ.001.05 Study Group. Consistent safety and tolerability of Valtoco(R) (diazepam nasal spray) in relationship to usage frequency in patients with seizure clusters: Interim results from a phase 3, long-term, open-label, repeat-dose safety study. Epilepsia Open. 2021 Sep;6(3):504-512. doi: 10.1002/epi4.12494. Epub 2021 May 13.
• Penovich P, Wheless JW, Hogan RE, Guerra C, Cook DF, Carrazana E, Rabinowicz AL. Examining the patient and caregiver experience with diazepam nasal spray for seizure clusters: Results from an exit survey of a phase 3, open-label, repeat-dose safety study. Epilepsy Behav. 2021 Aug;121(Pt A):108013. doi: 10.1016/j.yebeh.2021.108013. Epub 2021 May 19.

Drugs

Indications