Protocol Summary

Protocol No.: OCR14673

Protocol Title: 1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients

Principal Investigator: Rahman, Maryam

Objective: 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.

Description: 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.

Phase: NA

Age Group: Adult

Age: 18 Years - N/A

Gender: All

Scope: Local

Treatment:
Both arms will receive Levetiracetam extended release 1000 mg taken by mouth, once daily.
Arm 1: 1 Week of Levetiracetam extended release
Arm 2: 6 Weeks of Levetiracetam extended release

Detailed Eligibility:
INCLUSION CRITERIA:
1. 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.
2. Able to be randomized prior to or up to 48 hours after surgery.
EXCLUSION CRITERIA:
1. No known history of seizure activity.
2. Pregnant or breastfeeding.
3. Renal dysfunction (CrCl 4. Known history of depression.
5. Allergy to levetiracetam.

Applicable Conditions:

  • Brain and Nervous System
  • Participation Institution:

  • UF Gainesville : Ashley Lockerman, Jessica Smith
  • Contact:
    Jessica Smith, RN, BSN
    Phone: +1 352-273-9000
    Email: jessica.smith@neurosurgery.ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02334722