Clinical Trial: A Study to Determine the Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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®)
Brief Summary: This is a multi-center, open-label, crossover, pharmacokinetic, bioavailability study involving adolescents and adults with refractory (drug-resistant) epilepsy
Detailed Summary: 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.
Sponsor: Acorda Therapeutics
Current Primary Outcome:
- Maximum measured plasma concentration (Cmax) [ Time Frame: baseline, up to 24 hours post-dose ]
- Time to maximum measured plasma concentration (tmax) [ Time Frame: baseline, up to 24 hours post-dose ]
- Area under the concentration curve (AUC) values [ Time Frame: baseline, up to 24 hours post-dose ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Focused nasal exam [ Time Frame: pre-dose (day 1) up to 24 hours post-dose (up to day 31) ]
- Smell Identification Test (SIT) [ Time Frame: day 1 up to day 31 ]
- Taste change questionnaire [ Time Frame: up to 24 hours post-dose ]
- Number of participants with serious and non-serious adverse events [ Time Frame: up to 33 days ]
Original Secondary Outcome:
- Nasal irritation after a single dose [ Time Frame: pre-dose (day 1) up to 24 hours post-dose (up to day 31) ]
- Change in olfaction after a single dose [ Time Frame: day 1 up to day 31 ]
- Reported changes in taste after a single dose [ Time Frame: up to 24 hours post-dose ]
- Number of participants with serious and non-serious adverse events [ Time Frame: up to 33 days ]
Information By: Acorda Therapeutics
Dates:
Date Received: June 15, 2015
Date Started: June 2015
Date Completion:
Last Updated: February 17, 2017
Last Verified: February 2017