Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
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
1 other identifier
interventional
78
1 country
22
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2015
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 15, 2015
CompletedFirst Posted
Study publicly available on registry
June 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
October 16, 2018
CompletedOctober 16, 2018
September 1, 2018
11 months
June 15, 2015
November 8, 2017
September 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AUC 0-24h
Relative bioavailability based on area under time plasma concentration curve.
24 hours
Cmax
Relative bioavailability based on maximum observed plasma concentration.
24 hours
Secondary Outcomes (4)
Focused Nasal Exam (Part A)
pre-dose (day 1) up to 24 hours post-dose
Focused Nasal Exam (Part B)
pre-dose (day 1) up to 24 hours post-dose
Smell Identification Test (SIT)
day 1 up to day 31
Taste Change Questionnaire
Up to 24 hours
Study Arms (2)
diazepam nasal spray (DZNS)
EXPERIMENTALOne dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam rectal gel (DRG)
ACTIVE COMPARATORA single rectal dose of diazepam will be administered to subjects according to the Diastat prescribing information.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of refractory epilepsy
- Body weight 26 to 111 kilogram (kg) inclusive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Acorda Site #115
Little Rock, Arkansas, 72205, United States
Acorda Site #127
Washington D.C., District of Columbia, 20010, United States
Acorda Site #101
Tampa, Florida, 33606, United States
Acorda Site #125
Honolulu, Hawaii, 96817, United States
Acorda Site #104
Lexington, Kentucky, 40513, United States
Acorda Site #111
Baltimore, Maryland, 21201, United States
Acorda Site #102
Bethesda, Maryland, 20817, United States
Acorda Site #110
Ann Arbor, Michigan, 48105, United States
Acorda Site #117
Jackson, Mississippi, 39216, United States
Acorda Site #112
St Louis, Missouri, 63131, United States
Acorda Site #128
Edison, New Jersey, 08818, United States
Acorda Site #121
Hackensack, New Jersey, 07601, United States
Acorda Site #123
Amherst, New York, 14226, United States
Acorda Site #119
Rochester, New York, 14642, United States
Acorda Site #132
Chapel Hill, North Carolina, 27599, United States
Acorda Site #114
Portland, Oregon, 97239, United States
Acorda Site #116
Philadelphia, Pennsylvania, 19104, United States
Acorda Site #105
Philadelphia, Pennsylvania, 19107, United States
Acorda Site #130
Memphis, Tennessee, 38105, United States
Acorda Site #103
Bellaire, Texas, 77401, United States
Acorda Site #122
Dallas, Texas, 75251, United States
Acorda Site #108
Houston, Texas, 77004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lee Min Jae, Associate Manager
- Organization
- SK Bio-pharmaceuticals Co, Ltd
Study Officials
- STUDY DIRECTOR
Lee Min Jae
SK Biopharmaceuticals Co, Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2015
First Posted
June 17, 2015
Study Start
June 1, 2015
Primary Completion
May 1, 2016
Study Completion
July 1, 2016
Last Updated
October 16, 2018
Results First Posted
October 16, 2018
Record last verified: 2018-09