drugset
drugset / Trial / NCT05076838

Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

NCT05076838 ↗

Phase 1/2 Completed 35 enrolled Neurelis, Inc.
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

Drugs

EvaluationDrugModalityDoseRoute
Subject Diazepam Small molecule 5 mg Intranasal
Subject Diazepam Small molecule 10 mg Intranasal
Subject Diazepam Small molecule 15 mg Intranasal

Indications

epilepsy