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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acorda Therapeutics
• Treatments: Diazepam

Criteria

Inclusion Criteria:

• Provide signed informed consent for study participation.

• General good health with no clinically significant unstable abnormalities.

• Diagnosis of epilepsy.

Exclusion Criteria:

• 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.