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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00571155
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : August 20, 2009
Sponsor:
Information provided by:

Study Description
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

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
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

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
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

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
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: August 20, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Seizures
Brain Neoplasms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs