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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00454935 |
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Date of registration:
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30/03/2007 |
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Primary sponsor: |
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Public title:
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Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy
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Scientific title:
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Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00454935 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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J.J. Reijneveld, dr |
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Address:
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Telephone:
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+(31)20-4442821 |
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Email:
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jc.reijneveld@vumc.nl |
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Affiliation:
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Name:
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J.C. Reijneveld, dr |
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Address:
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Telephone:
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+(31)20-4442821 |
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Email:
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jc.reijneveld@vumc.nl |
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Affiliation:
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Name:
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J.J. Heimans, prof. dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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VU University Medical Center |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Glioma
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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EPI-GLIO-LEV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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