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

Last updated: August 19, 2009
Sponsor: University Hospital Tuebingen
Overall Status: Completed

Phase

4

Condition

Glioblastoma Multiforme

Epilepsy

Astrocytoma

Treatment

N/A

Clinical Study ID

NCT00571155
HELLO-Study 2007
EudraCT Number: 2007-005063-96
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • treatment with other antiepileptic drugs other than levetiracetam in the last sevendays 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

Study Design

Total Participants: 30
Study Start date:
December 01, 2007
Estimated Completion Date:
August 31, 2009

Connect with a study center

  • University Hospital Tuebingen, Department of General Neurology

    Tuebingen, Baden-Wuerttemberg 72076
    Germany

    Site Not Available

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