Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention

NCT00618436 | Completed Phase 4 Results DMC

• 1 other identifier: 06-4-6-7
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Subarachnoid Hemorrhage

Keywords

Seizures; Traumatic Brain Injury; Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Seizure Incidence

  This was the number of patients in each group who demonstrated seizure activity during the course of the study

  Duration of study, up to 6 months after the injury

Secondary Outcomes (3)

• Extended Glasgow Outcome Score

  at discharge; 3 and 6 months following injury

• Disability Rating Scale (DRS)

  Discharge; 3 and 6 months following injury

• Incidence of Adverse Events

  discharge; 3 and 6 months following injury

Study Arms (2)

Levetiracetam

ACTIVE COMPARATOR

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.

Drug: Levetiracetam

Phenytoin

ACTIVE COMPARATOR

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.

Drug: Phenytoin

Interventions

Levetiracetam DRUG

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.

Also known as: Keppra

Levetiracetam

Phenytoin DRUG

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.

Also known as: Dilantin

Phenytoin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Mayfield Clinic & Spine Institute: collaborator

Study Sites (1)

University of Cincinnati Hospital

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• 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.

  PMID: 22342434 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Seizures

Interventions

Levetiracetam; Phenytoin

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydantoins; Imidazolidines; Imidazoles; Azoles

Results Point of Contact

• Title: Dr. Lori Shutter
• Organization: University of Pittsburgh

shutterla@upmc.edu

1-412-647-8410

Study Officials

• Lori Shutter, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neurocritical Care Fellowship Program

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 20, 2008
• Study Start: August 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 7, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-03

Locations

US (1)