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

Phase 4

Completed

• Conditions: Brain Neoplasms; Brain Tumors; Brain Cancer; Cancer of the Brain; Seizure; Cancer of Brain
• Interventions: Drug: Levetiracetam

• Registration Number: NCT02334722
• Lead Sponsor: University of Florida

Brief 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.

Study Timeline

• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-08
• Study Start: 2015-08-05
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-07
• Results First Submitted: 2021-10-05
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Results First Posted: 2021-12-15
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 Week Levetiracetam	Levetiracetam	Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.
1 Week Levetiracetam	Levetiracetam	Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.

Primary Outcome Measures

Name	Time	Method
Change in Neurotoxicity Scale Scores	Baseline to 6 weeks	The Neurotoxicity Scale is as a validated 27 question, patient-reported measure for assessing the adverse effects of antiepileptic drugs on cognitive function. Patients self-report "no problem", "a mild problem", "a moderate problem" or "a serious problem" for each question corresponding to a score of 0, 1, 2, and 3, respectively. For each patient, the overall score was formed by summing scores in all 27 questions. The minimum possible score is 0 and the maximum possible total score is 81. A lower score indicates less toxicity when taking an antiepileptic drug. The outcome is a score change from baseline at the 6 week follow-up and is calculated by subtracting the baseline score from the 6 week follow-up score for each patient.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States