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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:
ClinicalTrials.gov Identifier:
NCT01417078
First Posted: August 16, 2011
Last Update Posted: March 29, 2017
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.
Information provided by (Responsible Party):
Acorda Therapeutics
Results First Submitted: December 16, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Drug: Diazepam

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Diazepam Nasal Spray Diazepam: single-dose; dosage in mg, based on patient body weight

Participant Flow:   Overall Study
    Diazepam Nasal Spray
STARTED   31 
COMPLETED   30 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population Number (N)=31 Pharmacokinetic Population N=30

Reporting Groups
  Description
Diazepam Nasal Spray Diazepam: single-dose; dosage in mg, based on patient body weight

Baseline Measures
   Diazepam Nasal Spray 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.2  (12.80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      18  58.1% 
Male      13  41.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      3   9.7% 
Not Hispanic or Latino      23  74.2% 
Unknown or Not Reported      5  16.1% 
Body Mass Index (BMI) 
[Units: (kg/m^2)]
Mean (Standard Deviation)
 26.3  (4.08) 


  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Secondary:   Number of Patients With Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: Pre-dose to 48 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Executive Medical Director - Clinical Development & Medical Affairs
Organization: Acorda Therapeutics, Inc.
phone: 914-347-4300 ext 5367
e-mail: dsquillacote@acorda.com



Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01417078     History of Changes
Other Study ID Numbers: DZNS-ARS-103
First Submitted: August 12, 2011
First Posted: August 16, 2011
Results First Submitted: December 16, 2016
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017



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