Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy

• Conditions: Epilepsy; Glioma

• Registration Number: NCT00454935
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

Detailed Description

Levetiracetam is a relatively novel anti-epileptic drug (AED), which has proven to be effective and well tolerated in many glioma patients with otherwise pharmacoresistant epilepsy. Moreover, levetiracetam has neither enzyme-inducing nor enzyme-inhibiting properties, which makes the drug particularly attractive for brain tumour patients, as they frequently receive chemotherapy and/or corticosteroids. Therefore, levetiracetam is the anti-epileptic drug of choice post-operatively in glioma patients suffering from epilepsy. Unfortunately, even with levetiracetam, a proportion of glioma patients is not free of seizures. It is unclear, however, which glioma patients benefit from levetiracetam treatment. It is suggested that the expression of protein SV2A is correlated with clinical response to levetiracetam. The determination of SV2A expression in brain (tumour) tissue might be used as a predictive tool for response to levetiracetam.

Objective of this study: Correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

Study Timeline

• Study First Submitted: 2007-03-30
• Study First Submitted QC: 2007-03-30
• Study Start: 2007-04
• Study First Posted: 2007-04-02
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-06
• Last Update Posted: 2008-06-09
• Study Completion: 2008-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• age > 18 years
• suffering from partial seizures, with or without secondary generalisation
• must have undergone surgery for their newly diagnosed or recurrent glioma not more than 42 days previously
• treated with levetiracetam
• histologically proven astrocytoma grade II or III, oligodendroglioma grade II or III, oligoastrocytoma grade II or III, or glioblastoma multiforme according to the World Health Organisation (WHO) classification of tumours affecting the central nervous system
• written informed consent

Exclusion Criteria

• Women who are pregnant or lactating
• Patients who do not have a basic proficiency of the Dutch language,or are unable to communicate adequately will also be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to correlate the efficacy of post-operative levetiracetam monotherapy in newly diagnosed glioma patients suffering from epilepsy with expression of synaptic vesicle protein 2A (SV2A).	6 months

Secondary Outcome Measures

Name	Time	Method
to determine the impact of levetiracetam monotherapy on neurocognitive functioning, health-related quality of life, and epileptic brain activity as measured by MEG, in newly diagnosed glioma patients with epilepsy	6 months

Trial Locations

Locations (1)

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands