1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients
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|ClinicalTrials.gov Identifier: NCT02334722|
Recruitment Status : Completed
First Posted : January 8, 2015
Results First Posted : December 15, 2021
Last Update Posted : December 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Brain Neoplasms Brain Cancer Brain Tumors Cancer of the Brain Cancer of Brain Seizure||Drug: Levetiracetam||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Shortened Antiepileptic Drug (AED) Course in Surgical Brain Tumor Patients: A Randomized Trial|
|Actual Study Start Date :||August 5, 2015|
|Actual Primary Completion Date :||October 7, 2020|
|Actual Study Completion Date :||October 7, 2020|
Experimental: 1 Week Levetiracetam
Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.
Other Name: Keppra
Active Comparator: 6 Week Levetiracetam
Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.
Other Name: Keppra
- Change in Neurotoxicity Scale Scores [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334722
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Maryam Rahman, MS, MD||University of Florida|