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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00571155
First received: December 10, 2007
Last updated: August 19, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Primary Brain Tumor
Epilepsy
Drug: levetiracetam
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: levetiracetam
oral and intravenous dosing 2000-3000 mg per day
Other Name: Keppra

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571155

Locations
Germany
University Hospital Tuebingen, Department of General Neurology
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Michael Weller, MD University-Hospital of Tuebingen, Department of General Neurology
  More Information

No publications provided by University Hospital Tuebingen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Michael Weller, University Hospital Tuebingen, Department of General Neurology
ClinicalTrials.gov Identifier: NCT00571155     History of Changes
Other Study ID Numbers: HELLO-Study 2007, EudraCT Number: 2007-005063-96
Study First Received: December 10, 2007
Last Updated: August 19, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Brain Neoplasms
Epilepsy
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014