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

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ClinicalTrials.gov Identifier: NCT00571155
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : August 20, 2009
Sponsor:
Information provided by:
University Hospital Tuebingen

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Primary Brain Tumor Epilepsy Drug: levetiracetam Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : December 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

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Arms and Interventions
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Arm Intervention/treatment
1 Drug: levetiracetam
oral and intravenous dosing 2000-3000 mg per day
Other Name: Keppra


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571155


Locations
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Germany
University Hospital Tuebingen, Department of General Neurology
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Michael Weller, MD University-Hospital of Tuebingen, Department of General Neurology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Michael Weller, University Hospital Tuebingen, Department of General Neurology
ClinicalTrials.gov Identifier: NCT00571155    
Other Study ID Numbers: HELLO-Study 2007
EudraCT Number: 2007-005063-96
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: August 20, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Brain Neoplasms
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Central Nervous System Neoplasms
 Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Levetiracetam
Anticonvulsants
Nootropic Agents