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

University of Florida

Status and phase: Completed; Phase 4

Conditions: Seizure; Brain Tumors; Cancer of Brain; Brain Cancer; Brain Neoplasms; Cancer of the Brain

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Other

Identifiers

NCT02334722

IRB201400876

OCR14673 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to see if there are any differences in patient reported neurotoxicity between patients who receive Levetiracetam tablets for one week after surgery to remove a brain tumor versus those who receive Levetiracetam 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.

Full 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 for 1 week results in less neurotoxicity than taking it for 6 weeks.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

1 Week Levetiracetam

Experimental group

Description:

Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.

Treatment:

Drug: Levetiracetam

6 Week Levetiracetam

Active Comparator group

Description:

Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.

Treatment:

Drug: Levetiracetam