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IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures

This study has been completed.
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Debra Houry, MD, MPH, Emory University
ClinicalTrials.gov Identifier:
NCT00510783
First received: July 31, 2007
Last updated: November 18, 2013
Last verified: November 2013
Results First Received: January 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tonic-clonic Seizure
Interventions: Drug: Keppra
Drug: Fosphenytoin
Drug: Dilantin

  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
Study completed

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
study completed

Reporting Groups
  Description
Phenytoin/Fosphenytoin Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
Levetiracetam Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).

Participant Flow:   Overall Study
    Phenytoin/Fosphenytoin     Levetiracetam  
STARTED     82     76  
COMPLETED     51     47  
NOT COMPLETED     31     29  
Lost to Follow-up                 29                 25  
Withdrawal by Subject                 2                 3  
Protocol Violation                 0                 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.
No text entered.

Reporting Groups
  Description
Phenytoin/Fosphenytoin Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
Levetiracetam Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
Total Total of all reporting groups

Baseline Measures
    Phenytoin/Fosphenytoin     Levetiracetam     Total  
Number of Participants  
[units: participants]
  82     76     158  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     80     73     153  
>=65 years     2     3     5  
Age  
[units: years]
Mean ± Standard Deviation
  51.80  ± 106.459     65.79  ± 154.721     58.53  ± 131.651  
Gender  
[units: participants]
     
Female     56     53     109  
Male     26     23     49  
Region of Enrollment  
[units: participants]
     
United States     82     76     158  



  Outcome Measures

1.  Primary:   Number of Participants Who Experienced a Recurrent Seizure After Treatment.   [ Time Frame: 24 hours ]


  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
Several patients were lost to follow-up.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Brittney Copeland
Organization: Emory
phone: 404-616-0301
e-mail: bcopel3@emory.edu


No publications provided


Responsible Party: Debra Houry, MD, MPH, Emory University
ClinicalTrials.gov Identifier: NCT00510783     History of Changes
Obsolete Identifiers: NCT00832858
Other Study ID Numbers: IRB00002266
Study First Received: July 31, 2007
Results First Received: January 8, 2011
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board