Epilepsy, Primary Brain Tumor
Conditions
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.
Interventions
DRUGlevetiracetam
oral and intravenous dosing 2000-3000 mg per day
Sponsors
University Hospital Tuebingen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed