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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:
University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE December 10, 2007
First Posted Date  ICMJE December 11, 2007
Last Update Posted Date August 20, 2009
Study Start Date  ICMJE December 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00571155 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2007)
Efficacy, safety and tolerance of intravenous and oral levetiracetem in patients with primary brain tumors and symtomatic epilepsy in the period of neurosurgical intervention. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Brain Tumor
  • Epilepsy
Intervention  ICMJE Drug: levetiracetam
oral and intravenous dosing 2000-3000 mg per day
Other Name: Keppra
Study Arms  ICMJE 1
Intervention: Drug: levetiracetam
Publications * Bähr O, Hermisson M, Rona S, Rieger J, Nussbaum S, Körtvelyessy P, Franz K, Tatagiba M, Seifert V, Weller M, Steinbach JP. Intravenous and oral levetiracetam in patients with a suspected primary brain tumor and symptomatic seizures undergoing neurosurgery: the HELLO trial. Acta Neurochir (Wien). 2012 Feb;154(2):229-35; discussion 235. doi: 10.1007/s00701-011-1144-9. Epub 2011 Sep 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 10, 2007)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00571155
Other Study ID Numbers  ICMJE HELLO-Study 2007
EudraCT Number: 2007-005063-96
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Michael Weller, University Hospital Tuebingen, Department of General Neurology
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Weller, MD University-Hospital of Tuebingen, Department of General Neurology
PRS Account University Hospital Tuebingen
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP