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

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ClinicalTrials.gov Identifier: NCT00510783
Recruitment Status : Completed
First Posted : August 2, 2007
Results First Posted : August 5, 2013
Last Update Posted : December 12, 2013
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Debra Houry, MD, MPH, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tonic-clonic Seizure
Interventions Drug: Keppra
Drug: Fosphenytoin
Drug: Dilantin
Enrollment 158
Recruitment Details Study completed
Pre-assignment Details study completed
Arm/Group Title Phenytoin/Fosphenytoin Levetiracetam
Hide Arm/Group Description 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). Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
Period Title: Overall Study
Started 82 76
Completed 51 47
Not Completed 31 29
Reason Not Completed
Lost to Follow-up             29             25
Withdrawal by Subject             2             3
Protocol Violation             0             1
Arm/Group Title Phenytoin/Fosphenytoin Levetiracetam Total
Hide Arm/Group Description 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). Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes). Total of all reporting groups
Overall Number of Baseline Participants 82 76 158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 76 participants 158 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
80
  97.6%
73
  96.1%
153
  96.8%
>=65 years
2
   2.4%
3
   3.9%
5
   3.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 76 participants 158 participants
51.80  (106.459) 65.79  (154.721) 58.53  (131.651)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 76 participants 158 participants
Female
56
  68.3%
53
  69.7%
109
  69.0%
Male
26
  31.7%
23
  30.3%
49
  31.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 82 participants 76 participants 158 participants
82 76 158
1.Primary Outcome
Title Number of Participants Who Experienced a Recurrent Seizure After Treatment.
Hide Description Recurrent seizure is defined as a seizure within 24 hours of treatment in the Emergency Department.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenytoin/Fosphenytoin Levetiracetam
Hide Arm/Group Description:
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).
Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
Overall Number of Participants Analyzed 82 76
Measure Type: Number
Unit of Measure: participants
2 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phenytoin/Fosphenytoin Levetiracetam
Hide Arm/Group Description 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). Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
All-Cause Mortality
Phenytoin/Fosphenytoin Levetiracetam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phenytoin/Fosphenytoin Levetiracetam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/82 (0.00%)      0/76 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phenytoin/Fosphenytoin Levetiracetam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/82 (48.78%)      19/76 (25.00%)    
Investigations     
Fatigue   4/82 (4.88%)  4 7/76 (9.21%)  7
Burning at the IV Site   11/82 (13.41%)  15 5/76 (6.58%)  5
Itching   8/82 (9.76%)  8 0/76 (0.00%)  0
Dizziness   17/82 (20.73%)  17 7/76 (9.21%)  7
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Brittney Copeland
Organization: Emory
Phone: 404-616-0301
EMail: bcopel3@emory.edu
Layout table for additonal information
Responsible Party: Debra Houry, MD, MPH, Emory University
ClinicalTrials.gov Identifier: NCT00510783     History of Changes
Obsolete Identifiers: NCT00832858
Other Study ID Numbers: IRB00002266
First Submitted: July 31, 2007
First Posted: August 2, 2007
Results First Submitted: January 8, 2011
Results First Posted: August 5, 2013
Last Update Posted: December 12, 2013