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Completed

NCT Number: NCT00571155

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

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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Key information

Conditions

Primary Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Epilepsy Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Tuebingen, Department of General Neurology

Tübingen, Baden-Wurttemberg, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

oral and intravenous dosing 2000-3000 mg per day

Other names: Keppra

Primary outcomes

  1. Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention.

    Time frame: 1 year

Secondary outcomes

  1. Efficacy, safety and tolerance of intravenous and oral levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Prospective Trial of Intravenous Levetiracetam in Patients With Primary Brain Tumors and at Least One Symptomatic Seizure Who Undergo Biopsy or Cytoreductive Surgery (HELLO-study)

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 11, 2007
Registry last updated
Aug 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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