drugset / Trial / NCT05076838
Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.
Timeline
- Start
- 2021-11-08
- Primary completion
- 2025-03-11
- Completion
- 2025-03-11
Publications
- Results Segal EB, Wheless JW, Zafar M, Shih EK, Ngo LY, Carrazana E, Rabinowicz AL; DIAZ.001.008 Study Group. Pharmacokinetics and 180-day safety of diazepam nasal spray in pediatric patients with epilepsy aged 2-5 years. Epilepsia. 2025 Sep;66(9):3231-3241. doi: 10.1111/epi.18473. Epub 2025 Jul 12.
- Segal EB, Wheless JW, Wolf SM, Zafar M, Renfroe JB, Lopez-Toledano MA, Ngo LY, Rabinowicz AL, Carrazana E. Safety and Local Tolerability of Diazepam Nasal Spray for Children With Epilepsy Aged 2-5 Years: Final Results of a Phase 1/2a Trial. J Child Neurol. 2026 Aug 26:8830738261474614. doi: 10.1177/08830738261474614. Online ahead of print.
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 |