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

Phase 4
18 Years
Open (Enrolling)
Epilepsy, Glioma

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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).

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

J.J. Heimans, prof. dr.

Investigator Role:

Study Chair

Investigator Affiliation:

VU University Medical Center


Netherlands: Medical Ethics Review Committee (METC)

Study ID:




Start Date:

April 2007

Completion Date:

October 2008

Related Keywords:

  • Epilepsy
  • Glioma
  • epilepsy
  • glioma
  • Epilepsy
  • Glioma