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1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02334722
Recruitment Status : Active, not recruiting
First Posted : January 8, 2015
Last Update Posted : April 2, 2021
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The purpose of this study is to see if there are any differences between patients who receive Levetiracetam extended-release tablets for one week after surgery to remove a brain tumor versus those who receive Levetiracetam extended-release 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.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Brain Cancer Brain Tumors Cancer of the Brain Cancer of Brain Seizure Drug: Levetiracetam extended release Phase 4

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 extended-release (Keppra XR) for 1 week results in less neurotoxicity than taking it for 6 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Shortened Antiepileptic Drug (AED) Course in Surgical Brain Tumor Patients: A Randomized Trial
Study Start Date : August 2015
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: 1 Week Levetiracetam extended release
Levetiracetam extended release 1000 mg taken by mouth, once daily, for one week.
Drug: Levetiracetam extended release
Other Name: Keppra XR

Active Comparator: 6 Week Levetiracetam extended release
Levetiracetam extended release 1000 mg taken by mouth, once daily, for six weeks.
Drug: Levetiracetam extended release
Other Name: Keppra XR

Primary Outcome Measures :
  1. Difference in Neurotoxicity Scale scores [ Time Frame: 6 weeks ]
    The Neurotoxicity Scale is as a patient-based report scale to assess the adverse effects of antiepileptic drugs on cognitive function.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02334722

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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
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Principal Investigator: Maryam Rahman, MS, MD University of Florida
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Responsible Party: University of Florida Identifier: NCT02334722    
Other Study ID Numbers: IRB201400876
OCR14673 ( Other Identifier: University of Florida )
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Brain Neoplasms
Neurologic Manifestations
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nootropic Agents