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
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Sponsor:
Emory University
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Debra Houry, MD, MPH, Emory University
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | Study completed |
Pre-assignment Details | study completed |
Arm/Group Title | Phenytoin/Fosphenytoin | Levetiracetam |
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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 |
Baseline Characteristics
Arm/Group Title | Phenytoin/Fosphenytoin | Levetiracetam | Total | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 82 participants | 76 participants | 158 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
80 97.6%
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73 96.1%
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153 96.8%
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>=65 years |
2 2.4%
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3 3.9%
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5 3.2%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 82 participants | 76 participants | 158 participants | |
Female |
56 68.3%
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53 69.7%
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109 69.0%
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Male |
26 31.7%
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23 30.3%
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49 31.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 82 participants | 76 participants | 158 participants |
82 | 76 | 158 |
Outcome Measures
Adverse Events
Limitations and Caveats
Several patients were lost to follow-up.
More Information
Results Point of Contact
Name/Title: | Brittney Copeland |
Organization: | Emory |
Phone: | 404-616-0301 |
EMail: | bcopel3@emory.edu |
Responsible Party: | Debra Houry, MD, MPH, Emory University |
ClinicalTrials.gov Identifier: | NCT00510783 |
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 |