A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- 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.
- 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.
- 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.
|Study Start Date:||September 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Experimental: Diazepam Nasal Spray||
single-dose; dosage in mg, based on patient body weight
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417078
|United States, Arizona|
|Barrow Neurology Clinics at St Joseph's Hospital|
|Phoenix, Arizona, United States, 85013|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Study Director:||David P Ward, MD||Neuronex, Inc.|