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Completed

NCT Number: NCT01417078

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barrow Neurology Clinics at St Joseph's Hospital, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diazepam

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2011
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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