Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy
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|ClinicalTrials.gov Identifier: NCT00454935|
Recruitment Status : Unknown
Verified June 2008 by VU University Medical Center.
Recruitment status was: Recruiting
First Posted : April 2, 2007
Last Update Posted : June 9, 2008
|Condition or disease||Phase|
|Epilepsy Glioma||Phase 4|
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 Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy|
|Study Start Date :||April 2007|
|Estimated Study Completion Date :||October 2008|
U.S. FDA Resources
- 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). [ Time Frame: 6 months ]
- 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 [ Time Frame: 6 months ]
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454935
|Contact: J.C. Reijneveld, dr||+(31)firstname.lastname@example.org|
|VU University Medical Center||Recruiting|
|Amsterdam, Netherlands, 1081 HV|
|Contact: J.J. Reijneveld, dr +(31)20-4442821 email@example.com|
|Principal Investigator: S.T. Toering, drs|
|Study Chair:||J.J. Heimans, prof. dr.||VU University Medical Center|