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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

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