A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode

Completed · Phase 2

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT01417078

Run by

Acorda Therapeutics

People needed

31

Starts

2011-09-01

Expected to finish

2013-03-01

Last updated by the study team

2017-03-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide signed informed consent for study participation.
• General good health with no clinically significant unstable abnormalities.
• Diagnosis of epilepsy.

You may not qualify if…

• 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.

Where it is running

• Barrow Neurology Clinics at St Joseph's Hospital — Phoenix, Arizona, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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