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

University Hospital Tuebingen

Status and phase: Completed; Phase 4

Conditions: Epilepsy; Primary Brain Tumor

Treatments: Drug: levetiracetam

Study type: Interventional

Funder types: Other

Identifiers

NCT00571155

EudraCT Number: 2007-005063-96

HELLO-Study 2007

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Other group

Treatment:

Drug: levetiracetam