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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diazepam Nasal Spray

Group Type EXPERIMENTAL

Diazepam

Intervention Type DRUG

single-dose; dosage in mg, based on patient body weight

Interventions

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Diazepam

single-dose; dosage in mg, based on patient body weight

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No