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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
Sponsor:
Collaborator:
Mayfield Clinic & Spine Institute
Information provided by (Responsible Party):
Lori Shutter, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE February 8, 2008
First Posted Date  ICMJE February 20, 2008
Results First Submitted Date  ICMJE August 29, 2013
Results First Posted Date  ICMJE April 7, 2014
Last Update Posted Date April 7, 2014
Study Start Date  ICMJE August 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
Seizure frequency [ Time Frame: Discharge, 3 and 6 months after injury ]
Change History Complete list of historical versions of study NCT00618436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
  • Extended GOSE [ Time Frame: at discharge; 3 and 6 months following injury ]
  • Disability Rating Scale [ Time Frame: Discharge; 3 and 6 months following injury ]
  • Incidence of Adverse Events [ Time Frame: discharge; 3 and 6 months following injury ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention
Official Title  ICMJE Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit
Brief Summary To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prevention in patients in the Neuroscience Intensive Care Unit will result in fewer side effects compared to the current standard of care anticonvulsant and will be at least as effective as the current standard of care in preventing clinical and sub-clinical seizure activity.
Detailed Description To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prophylaxis in the Neuroscience Intensive Care Unit will result in fewer adverse effects compared to the current standard of care anticonvulsant(phenytoin) and will be at least as effective as phenytoin in preventing clinical and sub-clinical seizure activity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Traumatic Brain Injury
  • Subarachnoid Hemorrhage
Intervention  ICMJE
  • Drug: Levetiracetam
    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
  • Drug: Phenytoin
    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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Levetiracetam
  • 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.
    Intervention: Drug: Phenytoin
Publications * Steinbaugh LA, Lindsell CJ, Shutter LA, Szaflarski JP. Initial EEG predicts outcomes in a trial of levetiracetam vs. fosphenytoin for seizure prevention. Epilepsy Behav. 2012 Mar;23(3):280-4. doi: 10.1016/j.yebeh.2011.12.005. Epub 2012 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2014)
52
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2008)
104
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with traumatic brain injury
  • Glasgow Coma Score (GCS) score 3-8(inclusive),or GCS motor score of 5 or less and abnormal admission CT scan showing intracranial pathology
  • Hemodynamically stable with a systolic BP >90 mm Hg
  • At least one reactive pupil
  • A negative pregnancy test in females
  • Age at least 18 years
  • Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for research form OR
  • Subjects with subarachnoid hemorrhage (SAH)
  • SAH documented by CT scan
  • Hunt-Hess grade 3-5, inclusive
  • Hemodynamically stable with a systolic BP> 90 mm Hg
  • At least one reactive pupil
  • A negative pregnancy test in females
  • Age of at least 18 years
  • Signed informed consent and HIPAA authorization for research form

Exclusion Criteria for enrollment

  • No venous access
  • Spinal cord injury
  • History of or CT confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage
  • Hemodynamically unstable
  • Suspected anoxic events
  • Other peripheral trauma likely to result in liver failure
  • Positive pregnancy test in females
  • Age less than 18 years of age
  • Known hypersensitivity to any anticonvulsant
  • An injury that, in the opinion of the principal investigator, has a high likelihood of death within the first 72 hours.
  • Any treatment, condition, or injury that contraindicates treatment with LEV (levetiracetam) or phenytoin (PHT).
  • Inability to obtain signed informed consent or HIPAA authorization for research.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00618436
Other Study ID Numbers  ICMJE 06-4-6-7
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lori Shutter, University of Pittsburgh
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Mayfield Clinic & Spine Institute
Investigators  ICMJE
Principal Investigator: Lori Shutter, MD University of Pittsburgh
PRS Account University of Cincinnati
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP