1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Brain Cancer, Neurology |
| Therapuetic Areas: | Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/27/2019 |
| Start Date: | August 2015 |
| End Date: | September 2020 |
| Contact: | Jessica Smith, RN |
| Email: | jessica.smith@neurosurgery.ufl.edu |
| Phone: | (352) 273-7773 |
A Shortened Antiepileptic Drug (AED) Course in Surgical Brain Tumor Patients: A Randomized Trial
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.
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.
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.
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.
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.
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Maryam Rahman, MS, MD
Phone: 352-273-7773
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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