A Phase 4 interventional study of Levetiracetam in Brain Neoplasms, Brain Cancer and Brain Tumors, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-15.
Sponsored by University of Florida · Phase 4, Interventional, and Treatment
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.
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 81 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.
Drug: Levetiracetam
Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.
Drug: Levetiracetam
Also known as: Keppra
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
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.
| Milestone | 1 Week Levetiracetam | 6 Week Levetiracetam |
|---|---|---|
| Started | 40 | 41 |
| Completed | 33 | 34 |
| Not completed | 7 | 7 |
| Withdrew: Lost to follow-up | 4 | 0 |
| Withdrew: 6 week questionnaire not completed | 2 | 0 |
| Withdrew: Unable to obtain medication | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Physician decision | 0 | 1 |
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.
| score on scale | 1 Week Levetiracetam | 6 Week Levetiracetam |
|---|---|---|
| Change in Neurotoxicity Scale Scores | -1 (-22 to 38) | -3.5 (-18 to 38) |
Collected over Adverse events will be collected from first dose of study drug to six week evaluation or sooner if the patient contacts their physician/study team about new symptoms/problems.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 Week Levetiracetam | 2/40 (5%) | 11/39 (28.2%) | 27/39 (69.2%) |
| 6 Week Levetiracetam | 0/41 (0%) | 7/37 (18.9%) | 22/37 (59.5%) |
| Event | 1 Week Levetiracetam | 6 Week Levetiracetam |
|---|---|---|
| AphasiaNervous system disorders | 3/39 | 0/37 |
| HydrocephalusNervous system disorders | 3/39 | 1/37 |
| SeizureNervous system disorders | 2/39 | 0/37 |
| Bowel ObstructionGastrointestinal disorders | 0/39 | 1/37 |
| Cerebral edemaNervous system disorders | 0/39 | 1/37 |
| WeaknessNervous system disorders | 0/39 | 1/37 |
| PseudomeningoceleNervous system disorders | 0/39 | 1/37 |
| SepsisInfections and infestations | 0/39 | 1/37 |
| Spinal HematomaVascular disorders | 0/39 | 1/37 |
| Mental Status ChangeNervous system disorders | 1/39 | 1/37 |
| Event | 1 Week Levetiracetam | 6 Week Levetiracetam |
|---|---|---|
| HeadacheNervous system disorders | 9/39 | 6/37 |
| FatigueGeneral disorders | 6/39 | 8/37 |
| NauseaGastrointestinal disorders | 7/39 | 5/37 |
| ConfusionNervous system disorders | 3/39 | 5/37 |
| InsomniaPsychiatric disorders | 2/39 | 4/37 |
| Mental Status ChangePsychiatric disorders | 4/39 | 3/37 |
| Incision PainGeneral disorders | 3/39 | 3/37 |
| Vision ChangeEye disorders | 2/39 | 3/37 |
| ConstipationGastrointestinal disorders | 3/39 | 1/37 |
| Facial SwellingGastrointestinal disorders | 3/39 | 2/37 |
Subjects were screened against eligibility criteria. Subjects with a history of seizures, depression or use of psychiatric medications, Beck-Depression Inventory score over 14, biopsy only or other factors were determined ineligible. Potential participants who may have been eligible also declined participation.
| Age, Continuous(years) | 1 Week Levetiracetam | 6 Week Levetiracetam | Total |
|---|---|---|---|
| Mean | 59.8 ± 13.7 | 49.9 ± 17.1 | 54.8 ± 16.2 |
| Sex: Female, Male(Participants) | 1 Week Levetiracetam | 6 Week Levetiracetam | Total |
|---|---|---|---|
| Female | 22 | 17 | 39 |
| Male | 18 | 24 | 42 |
| Ethnicity (NIH/OMB)(Participants) | 1 Week Levetiracetam | 6 Week Levetiracetam | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 37 | 39 | 76 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | 1 Week Levetiracetam | 6 Week Levetiracetam | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 37 | 38 | 75 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | 1 Week Levetiracetam | 6 Week Levetiracetam | Total |
|---|---|---|---|
| United States | 40 | 41 | 81 |
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