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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diazepam
Sponsored by
Acorda Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Barrow Neurology Clinics at St Joseph's Hospital
  • Johns Hopkins University
  • Thomas Jefferson University
  • Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diazepam Nasal Spray

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax),
Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Cmax. The mean Cmax value was adjusted to a 20 mg dose.
Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax)
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
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.

Secondary Outcome Measures

Number of Patients With Treatment Emergent Adverse Events (TEAEs)
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.

Full Information

First Posted
August 12, 2011
Last Updated
February 28, 2017
Sponsor
Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01417078
Brief Title
A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diazepam Nasal Spray
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Diazepam
Intervention Description
single-dose; dosage in mg, based on patient body weight
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax),
Description
Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Cmax. The mean Cmax value was adjusted to a 20 mg dose.
Time Frame
Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours
Title
Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax)
Description
Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Tmax. The mean Tmax value was adjusted to a 20 mg dose.
Time Frame
Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours
Title
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
Description
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.
Time Frame
Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours
Secondary Outcome Measure Information:
Title
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Pre-dose to 48 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P Ward, MD
Organizational Affiliation
Neuronex, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Barrow Neurology Clinics at St Joseph's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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