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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures Traumatic Brain Injury

Drug Information available for: Phenytoin Levetiracetam Phenytoin sodium

U.S. FDA Resources

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
Active Comparator: 1 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. Other Name: Keppra
Active Comparator: 2 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. Other Name: Dilantin

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

Keywords provided by Mayfield Clinic & Spine Institute:

Seizures
Traumatic Brain Injury
Subarachnoid Hemorrhage

Additional relevant MeSH terms:

Hemorrhage
Seizures
Subarachnoid Hemorrhage
Brain Injuries
Pathologic Processes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Etiracetam
Phenytoin
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012