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)
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Primary Brain Tumor, Epilepsy
Both
Primary Brain Tumor, Epilepsy
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Michael Weller, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University-Hospital of Tuebingen, Department of General Neurology
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
HELLO-Study 2007
NCT ID:
NCT00571155
Start Date:
December 2007
Completion Date:
August 2009
Related Keywords:
- Primary Brain Tumor
- Epilepsy
- Brain Neoplasms
- Epilepsy
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