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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01417078
First received: August 12, 2011
Last updated: January 27, 2014
Last verified: January 2014

August 12, 2011
January 27, 2014
September 2011
February 2013   (final data collection date for primary outcome measure)
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)).
Composite of Pharmacokinetics [ 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 ]
Complete list of historical versions of study NCT01417078 on ClinicalTrials.gov Archive Site
Number of Patients with Treatment Emergent Adverse Events [ Time Frame: Pre-dose to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Number of Patients with Treatment Emergent Adverse Events [ Time Frame: Pre-dose to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Systolic Blood Pressure [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Hematology Analytes [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Physical Exam Findings [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in 12-lead ECG Parameters [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Patient Alertness Observations [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Irritation and Inflammation Exam Findings [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Diastolic Blood Pressure [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Body Temperature [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Heart Rate [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Respiratory Rate [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Pulse Oximetry [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Clinical Chemistry Analytes [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Urinalysis Results [ Time Frame: Screening to 48 hours post-dose ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
Drug: Diazepam
single-dose; dosage in mg, based on patient body weight
Experimental: Diazepam Nasal Spray
Intervention: Drug: Diazepam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
March 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01417078
DZNS-ARS-103
No
Acorda Therapeutics
Acorda Therapeutics
Not Provided
Study Director: David P Ward, MD Neuronex, Inc.
Acorda Therapeutics
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP