Official Title: “Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit”

To show that the use of intravenous levitiracetam(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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

To show that the use of intravenous levitiracetam(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.

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Group 1-treatment with Levetiracetam
• Active Comparator: 2
  • Group 2-treatment with Phenytoin

Primary Measures

• Seizure frequency
  • Time Frame: Discharge, 3 and 6 months after injury
    Safety Issue?: No

Secondary Measures

• Extended GOSE
  • Time Frame: at discharge; 3 and 6 months following injury
    Safety Issue?: No
• Disability Rating Scale
  • Time Frame: Discharge; 3 and 6 months following injury
    Safety Issue?: No
• Incidence of adverse events
  • Time Frame: discharge; 3 and 6 months following injury
    Safety Issue?: Yes

Inclusion Criteria:

Subjects with traumatic brain injury:

• 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 >90mmHg
• At least one reactive pupil
• A negative pregnancy test in females
• Age at least 18 years
• Signed informed consent and HIPAA authorization for research form OR Subjects with subarachnoid hemorrhage
• SAH documented by CT scan
• Hunt-Hess grade 3-5, inclusive
• Hemodynamically stable with a systolic BP> 90mmHg
• At least one reactive pupil
• A negative pregnany test in females
• Age of at least 18 years
• Signed informed consent and HIPAA authorization for research form

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mayfield Clinic & Spine Institute

Overall Clinical Trial Officials and Contacts

Lori Shutter, MD Principal Investigator Mayfield Clinic Inc  

Overall Contact: Lori Shutter, MD 1-513-584-8072 shuttel@healthall.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00618436

Study ID Number: 06-4-6-7

ClinicalTrials.gov Identifier: NCT00618436

Health Authority: United States: Institutional Review Board