drugset / Trial / NCT02474407

Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)

NCT02474407

Phase 2 Terminated 78 enrolled Acorda Therapeutics
RandomizedCrossoverOpen-labelTreatment

Summary

This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1 comprises the subjects used to determine the relative bioavailability of DZNS versus DRG (Diastat)

Timeline

Start
2015-06
Primary completion
2016-05
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Diazepam Small molecule Intranasal

Indications