Nervous System Diseases

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Neoplasms

Seizures

Brain Neoplasms

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Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Anticonvulsants

Nootropic Agents

All Drugs and Chemicals

Levetiracetam

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.

Maryam Rahman, MS, MD

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 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients

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

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.

University of Florida

Participants at risk for all-cause mortality included any participant who signed consent to take part in the study. Participants at risk for Serious Adverse Events and Other (not including serious) Adverse Events included only participants who received study intervention.

Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.

Levetiracetam

1 Week Levetiracetam

Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.

Levetiracetam

6 Week Levetiracetam

Total

Age, Continuous

Percent of subjects that are male or female.

Sex: Female, Male

Percentage of participants identifying as a particular ethnicity in each arm

Ethnicity (NIH/OMB)

Percentage of participants identifying as a particular race in each arm

Race (NIH/OMB)

United States

Region of Enrollment

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.

Kristine Wynne

All patients taking levetiracetam 1000 mg daily, not stratified by dosing schedule.

Spots Global Cancer Trial Database for 1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients

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Interventions

Study Description

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