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

Epilepsy Clinical Trial

Official title:

An Open-Label Study to Determine the Pharmacokinetics of a Single Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode for Which Acute Treatment With a Benzodiazepine is Clinically Indicated

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417078
• Other study ID #: DZNS-ARS-103
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2011
• Last updated: January 27, 2014
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Diazepam
single-dose; dosage in mg, based on patient body weight

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Vanderbilt University	Nashville	Tennessee
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Barrow Neurology Clinics at St Joseph's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Pharmacokinetics (PK)	PK parameters include; The maximum measure plasma concentration (Cmax), time to maximum plasma concentration (Tmax) and the area under the concentration curve from time 0 to 12 hours (AUC(0-12)).	Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours	No
Secondary	Number of Patients with Treatment Emergent Adverse Events		Pre-dose to 48 hours post-dose	Yes