Back to results1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients
Primary Purpose
Brain Neoplasms, Brain Cancer, Brain Tumors
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Brain Neoplasms
Eligibility Criteria
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.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 Week Levetiracetam
6 Week Levetiracetam
Arm Description
Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.
Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02334722
First Posted
January 6, 2015
Last Updated
December 14, 2021
Sponsor
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT02334722
Brief Title
1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients
Official Title
A Shortened Antiepileptic Drug (AED) Course in Surgical Brain Tumor Patients: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2015 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
October 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms, Brain Cancer, Brain Tumors, Cancer of the Brain, Cancer of Brain, Seizure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Week Levetiracetam
Arm Type
Experimental
Arm Description
Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.
Arm Title
6 Week Levetiracetam
Arm Type
Active Comparator
Arm Description
Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Primary Outcome Measure Information:
Title
Change in Neurotoxicity Scale Scores
Description
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.
Time Frame
Baseline to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Rahman, MS, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients
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