Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.

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Detailed Description

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Conditions

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Primary Brain Tumor Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

levetiracetam

Intervention Type DRUG

oral and intravenous dosing 2000-3000 mg per day

Interventions

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levetiracetam

oral and intravenous dosing 2000-3000 mg per day

Intervention Type DRUG

Other Intervention Names

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Keppra

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years
* suspected primary brain tumor by imaging
* planned bioptical or cytoreductive surgery of the tumor
* symptomatic epilepsy
* Karnofsky performance score ≥ 70%
* women with child bearing potential must perform sufficient contraception
* sufficient haematologic, hepatic and renal function by laboratory testing

Exclusion Criteria

* treatment with other antiepileptic drugs other than levetiracetam in the last seven days before surgery
* known allergic reaction to levetiracetam or other serious side effects
* known, not tumor-induced, epilepsy
* previous brain surgery
* dementia
* participation in another clinical trial
* addiction to drugs or alcohol
* pregnant or breast feeding women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No