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

Phase 4

Completed

• Conditions: Epilepsy; Primary Brain Tumor
• Interventions: Drug: levetiracetam

• Registration Number: NCT00571155
• Lead Sponsor: University Hospital Tuebingen

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 available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Status Verified: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2009-08-19
• Last Update Posted: 2009-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	levetiracetam	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Tuebingen, Department of General Neurology; 🇩🇪 Tuebingen, Baden-Wuerttemberg, Germany