Assess the Safety and Efficacy of a Seizure Medication,Levetiracetam(LEV;Keppra),in Neuroscience Intensive Care Unit Patients - Full Text View

Sponsored by:	Mayfield Clinic & Spine Institute
Information provided by:	Mayfield Clinic & Spine Institute
ClinicalTrials.gov Identifier:	NCT00618436

Purpose

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.

Condition	Intervention
Traumatic Brain Injury Subarachnoid Hemorrhage	Drug: Levetiracetam Drug: Phenytoin

Genetics Home Reference related topics: pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures Traumatic Brain Injury

Drug Information available for: Phenytoin Levetiracetam Phenytoin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit

Further study details as provided by Mayfield Clinic & Spine Institute:

Primary Outcome Measures:

Seizure frequency [ Time Frame: Discharge, 3 and 6 months after injury ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Extended GOSE [ Time Frame: at discharge; 3 and 6 months following injury ] [ Designated as safety issue: No ]
Disability Rating Scale [ Time Frame: Discharge; 3 and 6 months following injury ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: discharge; 3 and 6 months following injury ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	104
Study Start Date:	August 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Group 1-treatment with Levetiracetam	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.
2: Active Comparator Group 2-treatment with Phenytoin	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618436

Contacts

Contact: Lori Shutter, MD	1-513-584-8072	shuttel@healthall.com
Contact: Raj Narayan, MD	1-513-475-7446	raj.narayan@uc.edu

Locations

United States, Ohio
University of Cincinnati Hospital	Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Suzanne Kempisty, RN 513-558-3590 kempiss@ucmail.uc.edu

Sponsors and Collaborators

Mayfield Clinic & Spine Institute

Investigators

Principal Investigator:

Lori Shutter, MD

Mayfield Clinic Inc

More Information

No publications provided

Responsible Party:	Mayfield Clinic Inc ( Lori Shutter, MD )
Study ID Numbers:	06-4-6-7
Study First Received:	February 8, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00618436 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayfield Clinic & Spine Institute:

Seizures
Traumatic Brain Injury
Subarachnoid Hemorrhage

Study placed in the following topic categories:

Craniocerebral Trauma
Nootropic Agents
Seizures
Vascular Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Intracranial Hemorrhages
Trauma, Nervous System

Hemorrhage
Brain Diseases
Cerebrovascular Disorders
Fosphenytoin
Phenytoin
Subarachnoid Hemorrhage
Etiracetam
Brain Injuries
Anticonvulsants

Additional relevant MeSH terms:

Craniocerebral Trauma
Nootropic Agents
Nervous System Diseases
Wounds and Injuries
Vascular Diseases
Disorders of Environmental Origin
Central Nervous System Diseases
Intracranial Hemorrhages
Trauma, Nervous System
Hemorrhage
Brain Diseases

Cerebrovascular Disorders
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Subarachnoid Hemorrhage
Etiracetam
Cardiovascular Diseases
Brain Injuries
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009