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