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

Acorda Therapeutics31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

DiazepamDRUG

single-dose; dosage in mg, based on patient body weight

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (4)

Barrow Neurology Clinics at St Joseph's Hospital

Phoenix, Arizona, United States

Johns Hopkins University

Baltimore, Maryland, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours

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.

Time frame: Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours

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.

Time frame: Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours

Secondary Outcomes

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.

Time frame: Pre-dose to 48 hours post-dose

Data from ClinicalTrials.gov

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