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

Refractory Epilepsy Clinical Trial

Official title:
An Open-Label, Randomized, Crossover Pharmacokinetic Study to Determine the Bioavailability, Safety and Tolerability of Single Doses of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®) in Patients With Refractory Epilepsy

Clinical Trial 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)

Clinical Trial Description

To determine the bioavailability of diazepam nasal spray versus diazepam rectal gel (Diastat®) under conditions of use in adolescent and adult persons with epilepsy (PWE) meeting the definition of refractory epilepsy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02474407
Study type Interventional
Source Acorda Therapeutics
Contact
Status Terminated
Phase Phase 2
Start date June 2015
Completion date July 2016
View Details
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