CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
Levetiracetam +1 moredrug
Likely dose
Levetiracetam 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00618436
NCT00618436Phase 4Completed
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Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit

University of Cincinnati·interventional·Posted Feb 20, 2008·Updated Apr 7, 2014

In Brief

A Phase 4 clinical trial evaluating Levetiracetam and Phenytoin for Traumatic Brain Injury and Subarachnoid Hemorrhage. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Brain Injury, Subarachnoid Hemorrhage
CountriesUnited States
CollaboratorsMayfield Clinic & Spine Institute

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 20, 2008
Enrollment StartAug 1, 2007
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.4 years ago

Interventions

Levetiracetamdrug

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.

Phenytoindrug

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.