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

NCT ID: NCT02334722

Last Updated: 2021-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-05

Study Completion Date

2020-10-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Neoplasms Brain Cancer Brain Tumors Cancer of the Brain Cancer of Brain Seizure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Week Levetiracetam

Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

6 Week Levetiracetam

Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.

Group Type ACTIVE_COMPARATOR

Levetiracetam

Intervention Type DRUG

Interventions

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Levetiracetam

Intervention Type DRUG

Other Intervention Names

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Keppra

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maryam Rahman, MS, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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OCR14673

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201400876

Identifier Type: -

Identifier Source: org_study_id