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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 : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE January 6, 2015
First Posted Date  ICMJE January 8, 2015
Last Update Posted Date February 25, 2019
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2015)
Seizure activity [ Time Frame: 6 weeks ]
The number of daily seizures reported.
Change History Complete list of historical versions of study NCT02334722 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE 1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients
Official Title  ICMJE A Shortened Antiepileptic Drug (AED) Course in Surgical Brain Tumor Patients: A Randomized Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Neoplasms
  • Brain Cancer
  • Brain Tumors
  • Cancer of the Brain
  • Cancer of Brain
  • Seizure
Intervention  ICMJE Drug: Levetiracetam extended release
Other Name: Keppra XR
Study Arms
  • Experimental: 1 Week Levetiracetam extended release
    Levetiracetam extended release 1000 mg taken by mouth, once daily, for one week.
    Intervention: Drug: Levetiracetam extended release
  • Active Comparator: 6 Week Levetiracetam extended release
    Levetiracetam extended release 1000 mg taken by mouth, once daily, for six weeks.
    Intervention: Drug: Levetiracetam extended release
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2015)
82
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2015)
234
Estimated Study Completion Date September 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Jessica Smith, RN (352) 273-7773 jessica.smith@neurosurgery.ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02334722
Other Study ID Numbers  ICMJE IRB201400876
OCR14673 ( Other Identifier: University of Florida )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maryam Rahman, MS, MD University of Florida
PRS Account University of Florida
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP