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

Brain Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334722
• Other study ID #: IRB201400876
• Secondary ID: OCR14673
• Status: Completed
• Phase: Phase 4
• Start date: August 5, 2015
• Est. completion date: October 7, 2020

Study information

• Verified date: December 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Levetiracetam

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Neurotoxicity Scale Scores	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.	Baseline to 6 weeks