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

Phase 2

Completed

• Conditions: Epilepsy
• Interventions: Drug: Diazepam

• Registration Number: NCT01417078
• Lead Sponsor: Acorda Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Study Start: 2011-09
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Disposition First Submitted: 2014-01-27
• Disposition First Submitted QC: 2014-01-27
• Disposition First Posted: 2014-02-27
• Results First Submitted: 2016-12-16
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-28
• Last Update Submitted: 2017-02-28
• Results First Posted: 2017-03-29
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diazepam Nasal Spray	Diazepam	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax)	Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours	Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Tmax.; The mean Tmax value was adjusted to a 20 mg dose.
Pharmacokinetic (PK) Parameter: Area Under The Concentration Curve From Time 0 to 12 Hours (AUC(0-12)) and AUC Time to Last Measurable Plasma Concentration	Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours	Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter AUC(0-12) and AUC(last).; The mean estimate of AUC(0-12) was adjusted to a 20 mg dose. AUC(last) was used for the calculation of AUC for nordiazepam. AUC(0-12) values could not be estimated for nordiazepam given that nordiazepam concentrations were rising between 6 and 12 hours.
Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax),	Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours	Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Cmax. The mean Cmax value was adjusted to a 20 mg dose.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Treatment Emergent Adverse Events (TEAEs)	Pre-dose to 48 hours post-dose	TEAEs refer to adverse events with start dates occurring after dosing. Treatment-Related TEAEs refer to those 'possibly' or 'probably' related to study drug.; Intensity definitions: * Mild: Usually transient, required no special treatment, and did not interfere with the patient's daily activities.; * Moderate: Usually caused a low degree of inconvenience or concern to the patient, and may have interfered with daily activities, but was usually ameliorated by simple therapeutic measures.; * Severe: Interrupted a patient's usual daily activities, and generally required systemic drug therapy or other treatment.

Trial Locations

Locations (4)

Barrow Neurology Clinics at St Joseph's Hospital; 🇺🇸 Phoenix, Arizona, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States