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

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ClinicalTrials.gov Identifier: NCT02334722
Recruitment Status : Recruiting
First Posted : January 8, 2015
Last Update Posted : August 7, 2019
Sponsor:
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)
Estimated 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 2020
Estimated Study Completion Date : September 2020

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
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


Contacts
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Contact: Jessica Smith, RN (352) 273-7773 jessica.smith@neurosurgery.ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Jessica Smith, RN    352-273-7773    jessica.smith@neurosurgery.ufl.edu   
Principal Investigator: Maryam Rahman, MS, MD         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Maryam Rahman, MS, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02334722     History of Changes
Other Study ID Numbers: IRB201400876
OCR14673 ( Other Identifier: University of Florida )
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Levetiracetam
Brain Neoplasms
Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Anticonvulsants
Nootropic Agents