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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.
 
ClinicalTrials.gov Identifier: NCT02334722
Recruitment Status : Completed
First Posted : January 8, 2015
Results First Posted : December 15, 2021
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Brain Cancer Brain Tumors Cancer of the Brain Cancer of Brain Seizure Drug: Levetiracetam 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 for 1 week results in less neurotoxicity than taking it for 6 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 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
Actual Study Start Date : August 5, 2015
Actual Primary Completion Date : October 7, 2020
Actual Study Completion Date : October 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: 1 Week Levetiracetam
Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.
Drug: Levetiracetam
Other Name: Keppra

Active Comparator: 6 Week Levetiracetam
Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.
Drug: Levetiracetam
Other Name: Keppra




Primary Outcome Measures :
  1. 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.



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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02334722


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Maryam Rahman, MS, MD University of Florida
  Study Documents (Full-Text)

Documents provided by University of Florida:
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02334722    
Other Study ID Numbers: IRB201400876
OCR14673 ( Other Identifier: University of Florida )
First Posted: January 8, 2015    Key Record Dates
Results First Posted: December 15, 2021
Last Update Posted: December 15, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Seizures
Neurologic Manifestations
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents