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DIAZ001.08 An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO with Open-Label Safety Period in Pediatric Subjects with Epilepsy

NCT05076838

An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO with Open-Label Safety Period in Pediatric Subjects with Epilepsy

Associated Conditions

Epilepsy

Principal Investigator

Sponsor

Neureils

This is a research study to evaluate the pharmacokinetics (PK), safety and tolerability after a single intranasal dose of VALTOCO (diazepam nasal spray), followed by a long-term safety period, where VALTOCO will be used “as needed”, in 2–5-year-old subjects