A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
|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.|
|ClinicalTrials.gov Identifier: NCT01417078|
Recruitment Status : Completed
First Posted : August 16, 2011
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Diazepam||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||March 2013|
|Experimental: Diazepam Nasal Spray||
single-dose; dosage in mg, based on patient body weight
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|