Clinical trial NCT02474407: Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Refractory Epilepsy
Keywords: Seizures
Epilepsy
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-06-17
Enrollment: 78
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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)

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of refractory epilepsy
* Body weight 26 to 111 kilogram (kg) inclusive
* Other inclusion criteria apply

Exclusion Criteria:

* Male or female subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product
* Female subject who is pregnant, breastfeeding, or planning to become pregnant
* Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
* Other exclusion criteria apply

Primary outcomes:
measure: AUC 0-24h
timeFrame: 24 hours
measure: Cmax
timeFrame: 24 hours
Secondary outcomes:
measure: Focused Nasal Exam (Part A)
timeFrame: pre-dose (day 1) up to 24 hours post-dose
measure: Focused Nasal Exam (Part B)
timeFrame: pre-dose (day 1) up to 24 hours post-dose
measure: Smell Identification Test (SIT)
timeFrame: day 1 up to day 31
measure: Taste Change Questionnaire
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Acorda Site #115
state: Arkansas
city: Washington
country: United States
facility: Acorda Site #127
state: District of Columbia
city: Tampa
country: United States
facility: Acorda Site #101
state: Florida
city: Honolulu
country: United States
facility: Acorda Site #125
state: Hawaii
city: Lexington
country: United States
facility: Acorda Site #104
state: Kentucky
city: Baltimore
country: United States
facility: Acorda Site #111
state: Maryland
city: Bethesda
country: United States
facility: Acorda Site #102
state: Maryland
city: Ann Arbor
country: United States
facility: Acorda Site #110
state: Michigan
city: Jackson
country: United States
facility: Acorda Site #117
state: Mississippi
city: Saint Louis
country: United States
facility: Acorda Site #112
state: Missouri
city: Edison
country: United States
facility: Acorda Site #128
state: New Jersey
city: Hackensack
country: United States
facility: Acorda Site #121
state: New Jersey
city: Amherst
country: United States
facility: Acorda Site #123
state: New York
city: Rochester
country: United States
facility: Acorda Site #119
state: New York
city: Chapel Hill
country: United States
facility: Acorda Site #132
state: North Carolina
city: Portland
country: United States
facility: Acorda Site #114
state: Oregon
city: Philadelphia
country: United States
facility: Acorda Site #116
state: Pennsylvania
city: Philadelphia
country: United States
facility: Acorda Site #105
state: Pennsylvania
city: Memphis
country: United States
facility: Acorda Site #130
state: Tennessee
city: Bellaire
country: United States
facility: Acorda Site #103
state: Texas
city: Dallas
country: United States
facility: Acorda Site #122
state: Texas
city: Houston
country: United States
facility: Acorda Site #108
state: Texas
Study officials:
affiliation: SK Biopharmaceuticals Co, Ltd
name: Lee Min Jae
role: STUDY_DIRECTOR
References: