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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Epilepsy Glioma

Keywords

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epilepsy glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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VU University Medical Centre

Principal Investigators

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J.J. Heimans, prof. dr.

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Locations

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VU University Medical Center

Amsterdam, Amsterdam, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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J.C. Reijneveld, dr

Role: CONTACT

Phone: +(31)20-4442821

Email: [email protected]

Facility Contacts

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J.J. Reijneveld, dr

Role: primary

Other Identifiers

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EPI-GLIO-LEV

Identifier Type: -

Identifier Source: org_study_id