Status:
COMPLETED
A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
Lead Sponsor:
Acorda Therapeutics
Conditions:
Epilepsy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray following a single dose in epileptic patients experiencing a seizure episode.
Eligibility Criteria
Inclusion
- Provide signed informed consent for study participation.
- General good health with no clinically significant unstable abnormalities.
- Diagnosis of epilepsy.
Exclusion
- Individuals receiving warfarin (Coumadin®) or dabigatran (Pradaxa®).
- Use of any investigational drug within 30 days.
- Blood or plasma donation within 30 days.
- Not willing or unable to tolerate blood draws.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01417078
Start Date
September 1 2011
End Date
March 1 2013
Last Update
March 29 2017
Active Locations (4)
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1
Barrow Neurology Clinics at St Joseph's Hospital
Phoenix, Arizona, United States, 85013
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
4
Vanderbilt University
Nashville, Tennessee, United States, 37232