Gainesville, Florida 32610


Purpose:

The purpose of this study is to see if there are any differences between patients who receive Levetiracetam extended-release tablets for one week after surgery to remove a brain tumor versus those who receive Levetiracetam extended-release tablets for six weeks after surgery. Specifically, we will see if one group has less side effects than the other, and whether or not one group has more seizures than the other.


Study summary:

Because seizures are one of the leading neurologic complications in brain tumor patients, neurosurgeons prescribe antiepileptic drugs (AEDs) to help prevent them. Although the American Academy of Neurology (AAN) guidelines recommend that AEDs be stopped after the first post-operative week in patients without seizures, there is no standard length of treatment and some patients may stay on AEDs indefinitely. In an attempt to develop clinical guidelines for AED use in post-operative brain tumor patients, we will try to determine if taking levetiracetam extended-release (Keppra XR) for 1 week results in less neurotoxicity than taking it for 6 weeks.


Criteria:

Inclusion Criteria: - Adult (>18 years of age and older) patients who have or will have undergone surgical resection or biopsy of a supratentorial brain tumor and are able to consent for themselves. - Able to be randomized prior to or up to 48 hours after surgery. Exclusion Criteria: - No known history of seizure activity. - Pregnant or breastfeeding. - Renal dysfunction (CrCl < 30ml/min). - Beck's Depression Inventory (BDI) ≥14 - Allergy to levetiracetam.


NCT ID:

NCT02334722


Primary Contact:

Principal Investigator
Maryam Rahman, MS, MD
University of Florida

Jessica Smith, RN
Phone: (352) 273-7773
Email: jessica.smith@neurosurgery.ufl.edu


Backup Contact:

N/A


Location Contact:

Gainesville, Florida 32610
United States

Jessica Smith, RN
Phone: 352-273-7773
Email: jessica.smith@neurosurgery.ufl.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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