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Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00319501
First received: April 27, 2006
Last updated: August 17, 2016
Last verified: July 2016
Results First Received: July 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Seizures
Epilepsies, Partial
Epilepsy, Complex Partial
Epilepsy, Generalized
Epilepsy
Interventions: Drug: Placebo
Drug: Vanquix Auto-Injector (Diazepam Injection)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 234 participants randomized, 71 (29 placebo, 42 diazepam) did not receive/attempt to receive treatment. Discontinuation prior to treatment due to: 3,0 protocol violations; 6,5 sponsor's request; 4,8 Principal Investigator request; 5,11 other; 0,2 lost to follow-up, and 9,10 withdrawn consent.

Reporting Groups
  Description
Diazepam During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
Placebo During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.

Participant Flow for 3 periods

Period 1:   Double-blind Period
    Diazepam   Placebo
STARTED   124 [1]   110 [1] 
Received Treatment   82   81 
COMPLETED   81   78 
NOT COMPLETED   43   32 
Withdrawal by Subject                0                3 
Sponsor Request                1                0 
Did not receive treatment                42                29 
[1] Randomized participants

Period 2:   Open-label Period
    Diazepam   Placebo
STARTED   161 [1]   0 
Received Treatment   128   0 
COMPLETED   45 [2]   0 
NOT COMPLETED   116   0 
Adverse Event                5                0 
Protocol Violation                6                0 
Withdrawal by Subject                38                0 
Principal Investigator decision                6                0 
Sponsor request                12                0 
Lost to Follow-up                5                0 
Did not receive treatment                33                0 
Not specified                11                0 
[1] Participants who continued to meet eligibility requirements
[2] Competed=continuing treatment

Period 3:   Open-label Extension Period
    Diazepam   Placebo
STARTED   51 [1]   0 
Received Treatment   33   0 
COMPLETED   0   0 
NOT COMPLETED   51   0 
Adverse Event                2                0 
Did not receive treatment                18                0 
Not specified                1                0 
Principal investigator decision                2                0 
Sponsor request                26                0 
Withdrawal by Subject                2                0 
[1] Eligible participants who chose to continue treatment



  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.
Participants who were randomized to receive treatment

Reporting Groups
  Description
Diazepam During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
Placebo During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
Total Total of all reporting groups

Baseline Measures
   Diazepam   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 124   110   234 
Age 
[Units: Years]
Mean (Standard Deviation)
 22.8  (15.98)   21.3  (12.92)   22.1  (14.61) 
Age, Customized 
[Units: Participants]
     
2 to 5 years   12   6   18 
6 to 11 years   18   14   32 
12 years and older   94   90   184 
Gender 
[Units: Participants]
     
Female   62   54   116 
Male   62   56   118 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   15   9   24 
Not Hispanic or Latino   109   101   210 
Unknown or Not Reported   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
White/Caucasian   104   89   193 
Black/African American   13   17   30 
Asian   2   2   4 
Native Hawaiian or other Pacific Islander   0   0   0 
American Indian or Alaska Native   0   0   0 
Other   5   2   7 
Missing   0   0   0 
Place of Residence 
[Units: Participants]
     
Home   123   107   230 
Foster home   0   1   1 
Group home   1   1   2 
Residential facility   0   1   1 
Other   0   0   0 
Height 
[Units: Centimeters]
Mean (Standard Deviation)
 154.2  (25.08)   154.5  (22.61)   154.4  (23.91) 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 61.0  (29.15)   58.9  (28.47)   60.0  (28.79) 


  Outcome Measures
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1.  Primary:   Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile)   [ Time Frame: From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period ]

2.  Primary:   Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period   [ Time Frame: From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period ]

3.  Secondary:   Number of Participants Requiring Rescue Medication During the Double-blind Period   [ Time Frame: From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period ]

4.  Secondary:   Number of Participants Requiring Emergency Department Visits During the Double-blind Period   [ Time Frame: From 15 minutes to 12 hours following study drug administration for onset of an episode of ARS during the Double-blind Period ]

5.  Secondary:   Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period   [ Time Frame: From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period ]

6.  Secondary:   Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period   [ Time Frame: Assessments completed at the end of each treated episode of ARS in the Double-blind Period ]

7.  Secondary:   Mean Score on Physician Global Treatment Assessment During the Double-blind Period   [ Time Frame: At Visit 2 and subsequent visits in the Double-blind Period ]

8.  Secondary:   Number of Participants Requiring Rescue Medication During the Open-label Period   [ Time Frame: From 15 minutes to 12 hours after study drug administration during the Open-label Period ]

9.  Secondary:   Number of Participants Requiring Emergency Department Visits During the Open-label Period   [ Time Frame: From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period ]

10.  Secondary:   Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period   [ Time Frame: From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period ]

11.  Secondary:   Mean Score on Caregiver Global Treatment Assessment During the Open-label Period   [ Time Frame: Assessments completed at the end of each treated episode of ARS in the Open-label Period ]

12.  Secondary:   Mean Score on Physician Global Treatment Assessment During the Open-label Period   [ Time Frame: From Visit 2 and subsequent visits in the Open-label Period to discharge or study termination ]


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00319501     History of Changes
Obsolete Identifiers: NCT01079156
Other Study ID Numbers: K826-05-3001
B4511001 ( Other Identifier: Alias Study Number )
Study First Received: April 27, 2006
Results First Received: July 6, 2016
Last Updated: August 17, 2016
Health Authority: United States: Food and Drug Administration