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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417078
First Posted: August 16, 2011
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Acorda Therapeutics
August 12, 2011
August 16, 2011
December 16, 2016
March 29, 2017
March 29, 2017
September 2011
February 2013   (Final data collection date for primary outcome measure)
  • Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax), [ Time Frame: 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.
  • Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 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 [ Time Frame: 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.

Composite of Pharmacokinetics [ Time Frame: Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours ]
Complete list of historical versions of study NCT01417078 on ClinicalTrials.gov Archive Site
Number of Patients With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 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.
  • Number of Patients with Treatment Emergent Adverse Events [ Time Frame: Pre-dose to 48 hours post-dose ]
  • Change from Baseline in Systolic Blood Pressure [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in Hematology Analytes [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in Physical Exam Findings [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in 12-lead ECG Parameters [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in Patient Alertness Observations [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in Irritation and Inflammation Exam Findings [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in Diastolic Blood Pressure [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in Body Temperature [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in Heart Rate [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in Respiratory Rate [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in Pulse Oximetry [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in Clinical Chemistry Analytes [ Time Frame: Screening to 48 hours post-dose ]
  • Change from Baseline in Urinalysis Results [ Time Frame: Screening to 48 hours post-dose ]
Not Provided
Not Provided
 
A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
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
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Epilepsy
Drug: Diazepam
single-dose; dosage in mg, based on patient body weight
Experimental: Diazepam Nasal Spray
Intervention: Drug: Diazepam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
March 2013
February 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01417078
DZNS-ARS-103
No
Not Provided
Not Provided
Acorda Therapeutics
Acorda Therapeutics
Not Provided
Study Director: David P Ward, MD Neuronex, Inc.
Acorda Therapeutics
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP