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

Epilepsy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571155
• Other study ID #: HELLO-Study 2007
• Secondary ID: EudraCT Number:
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2007
• Last updated: August 19, 2009
• Start date: December 2007
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms
• Epilepsy
• Primary Brain Tumor

Intervention

Drug:
• levetiracetam
oral and intravenous dosing 2000-3000 mg per day

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen, Department of General Neurology	Tuebingen	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention.		1 year	No
Secondary	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	Yes