Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention (Keppra)
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|ClinicalTrials.gov Identifier: NCT00618436|
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : April 7, 2014
Last Update Posted : April 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Subarachnoid Hemorrhage||Drug: Levetiracetam Drug: Phenytoin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit|
|Study Start Date :||August 2007|
|Primary Completion Date :||September 2009|
|Study Completion Date :||September 2009|
Active Comparator: Levetiracetam
Group 1 - The levetiracetam (Keppra®) group will receive a loading dose of 20 mg/kg IV over 15 minutes (rounded to the nearest 250mg) up to a maximum of 2000 mg, then started on maintenance dose (1000 mg, IV BID)as prophylaxis for 7 days.
Levetiracetam group will receive a loading dose of 20 mg/kg IV(rounded to nearest 250mg) to a maximum of 2000mg, then started on maintenance dose (1000 mg,IV q 12h) as prophylaxis for seven days.
Other Name: Keppra
Active Comparator: Phenytoin
Group 2-The phenytoin group will receive a loading dose of 20 mg/kg IV to a maximum of 2000mg, then started on maintenance dose at 5 mg/kg/day (rounded to nearest 100mg dose, IV, divided into three doses a day) as prophylaxis for 7 days. Phenytoin levels are to be checked daily and dose adjusted as needed to maintain therapeutic levels of 10-20 µg/dL.
The group will receive a loading dose of fosphenytoin 20 mg/kg IV to a maximum of 2000 mg, then started on maintenance dose of 5mg/kg/day, rounded to nearest 100mg dose, IV, q 12h for seven days.
Other Name: Dilantin
- Seizure Incidence [ Time Frame: Duration of study, up to 6 months after the injury ]This was the number of patients in each group who demonstrated seizure activity during the course of the study
- Extended Glasgow Outcome Score [ Time Frame: at discharge; 3 and 6 months following injury ]This is an 8 point validated scale that measures disability after brain injury. It is assessed through an in person exam or by phone interview at hospital discharge, 3 months and 6 months after injury. The categories are: 1 = dead; 2 = vegetative state; 3 = severe disability, low level; 4 = severe disability, high level; 5 = moderate disability, low level; 6 = moderate disability, high level; 7 = good recovery - low level; 8 = good recovery - high level. Specific questions and activities are assessed to determine into which category the patient falls.
- Disability Rating Scale (DRS) [ Time Frame: Discharge; 3 and 6 months following injury ]The Disability rating scale (DRS) is frequently used in the rehabilitation literature as a measure of disability. It is a reliable, easily performed test that assesses 8 items (eye opening, verbalization, motor response, feeding, toileting, grooming, level of functioning, employability), and assigns each a numerical score ranging from 0 - 5 based on the category. The domains these 8 items are felt to assess include: alertness, cognition for self-care, dependence, and psychosocial adaptability. The scoring range is from 0-30, with increasing disability levels assigned to higher numerical values. The total DRS is then dichotomized into favorable (disability = none, mild, partial or moderate disability) and unfavorable (disability = moderately severe, severe, extremely severe, vegetative state, extreme vegetative state, death) outcomes. A DRS score of 0-6 was favorable, with any score greater than 6 categorized as unfavorable.
- Incidence of Adverse Events [ Time Frame: discharge; 3 and 6 months following injury ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618436
|United States, Ohio|
|University of Cincinnati Hospital|
|Cincinnati, Ohio, United States, 45220|
|Principal Investigator:||Lori Shutter, MD||University of Pittsburgh|