Brain Cancer, Brain Neoplasms, Brain Tumors, Cancer of Brain, Cancer of the Brain, Seizure
Conditions
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.
Interventions
DRUGLevetiracetam
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
The first subject was enrolled in this trial on 8/5/2015 and the last on 8/27/2020 at an academic medical center in a Neurosurgical inpatient/outpatient setting. Potential participants were adult (\>18 years of age and older) patients, with no seizure history, who had or will have had undergone surgical resection of a supratentorial brain tumor and were able to consent for themselves.
Participants by arm
| Arm | Count |
|---|---|
| 1 Week Levetiracetam Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.
Levetiracetam | 40 |
| 6 Week Levetiracetam Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.
Levetiracetam | 41 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 6 week questionnaire not completed | 2 | 0 |
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Unable to obtain medication | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | 1 Week Levetiracetam | Total | 6 Week Levetiracetam |
|---|---|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 13.7 | 54.8 years STANDARD_DEVIATION 16.2 | 49.9 years STANDARD_DEVIATION 17.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 76 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 75 Participants | 38 Participants |
| Region of Enrollment United States | 40 participants | 81 participants | 41 participants |
| Sex: Female, Male Female | 22 Participants | 39 Participants | 17 Participants |
| Sex: Female, Male Male | 18 Participants | 42 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 40 | 0 / 41 |
| other Total, other adverse events | 27 / 39 | 22 / 37 |
| serious Total, serious adverse events | 11 / 39 | 7 / 37 |
Outcome results
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.
Time frame: Baseline to 6 weeks
Population: All patients taking levetiracetam 1000 mg daily, not stratified by dosing schedule.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1 Week Levetiracetam | Change in Neurotoxicity Scale Scores | -1 score on scale |
| 6 Week Levetiracetam | Change in Neurotoxicity Scale Scores | -3.5 score on scale |
p-value: 0.7824Wilcoxon (Mann-Whitney)