NCT02334722

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

A Shortened Antiepileptic Drug (AED) Course in Surgical Brain Tumor Patients: A Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Brain Neoplasms
• Brain Cancer
• Brain Tumors
• Cancer of the Brain
• Cancer of Brain
• Seizure

Interventions

Type	Name	Description
DRUG	Levetiracetam

Timeline

• Start date: 2015-08-05
• Primary completion: 2020-10-07
• Completion: 2020-10-07
• First posted: 2015-01-08
• Last updated: 2021-12-15
• Results posted: 2021-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study