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

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Completed
CT.gov ID
NCT00571155
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
20
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2007
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Aug 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Other: 1

Drug: levetiracetam
oral and intravenous dosing 2000-3000 mg per day
Other Names:
  • 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. [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. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00571155
    Other Study ID Numbers:
    • HELLO-Study 2007
    • EudraCT Number: 2007-005063-96
    First Posted:
    Dec 11, 2007
    Last Update Posted:
    Aug 20, 2009
    Last Verified:
    Aug 1, 2009
    Additional relevant MeSH terms:
    Brain Neoplasms
    Seizures
    Levetiracetam

    Study Results

    No Results Posted as of Aug 20, 2009