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

Acorda Therapeutics

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: Diazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01417078

DZNS-ARS-103

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Diazepam Nasal Spray

Experimental group

Treatment:

Drug: Diazepam