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