- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02334722
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 Week Levetiracetam
Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.
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Other Names:
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Active Comparator: 6 Week Levetiracetam
Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline to 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maryam Rahman, MS, MD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201400876
- OCR14673 (Other Identifier: University of Florida)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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