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

This study has been completed.
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
First received: August 12, 2011
Last updated: January 27, 2014
Last verified: January 2014
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.

Condition Intervention Phase
Drug: Diazepam
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Composite of Pharmacokinetics (PK) [ Time Frame: Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours ] [ Designated as safety issue: No ]
    PK parameters include; The maximum measure plasma concentration (Cmax), time to maximum plasma concentration (Tmax) and the area under the concentration curve from time 0 to 12 hours (AUC(0-12)).

Secondary Outcome Measures:
  • Number of Patients with Treatment Emergent Adverse Events [ Time Frame: Pre-dose to 48 hours post-dose ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diazepam Nasal Spray Drug: Diazepam
single-dose; dosage in mg, based on patient body weight


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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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
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Acorda Therapeutics
Study Director: David P Ward, MD Neuronex, Inc.
  More Information

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01417078     History of Changes
Other Study ID Numbers: DZNS-ARS-103 
Study First Received: August 12, 2011
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Autonomic Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 26, 2016