EpilepsyNCT00454935
Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy
An observational study of Epilepsy and Glioma, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2007to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult (> 18 years) glioma patients who suffer from partial seizures, with or without secondary generalisation, preoperatively. Patients must have undergone surgery for their newly diagnosed or recurrent glioma not more than 42 days previously and be treated with levetiracetam monotherapy at the time of inclusion.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
VU University Medical Center
Amsterdam, Amsterdam, 1081 HV
J.J. Reijneveld, dr, +(31)20-4442821, jc.reijneveld@vumc.nl
S.T. Toering, drs
About this study
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.
Read the 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.
- Keywords
- epilepsy, glioma
- Medical subject headings
- Epilepsy, Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study startApr 2007
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Medical Center Haaglanden
- Investigators
- J.J. Heimans, prof. dr., Study chair, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454935
- Sponsor's protocol ID
- EPI-GLIO-LEV
- Status last verified
- Jun 2008
- First submitted
- 30 Mar 2007
- Last updated
- 9 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT00454935
- Acronym / sponsor ID
- EPI-GLIO-LEV
- Keywords
- epilepsy, glioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Medical Center Haaglanden
- Study start
- Apr 2007
- Study completion
- Oct 2008 (estimated)
- First posted
- 2 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult (> 18 years) glioma patients who suffer from partial seizures, with or without secondary generalisation, preoperatively. Patients must have undergone surgery for their newly diagnosed or recurrent glioma not more than 42 days previously and be treated with levetiracetam monotherapy at the time of inclusion.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J.J. Heimans, prof. dr. study chair
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Glioma, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact J.C. Reijneveld, dr (+(31)20-4442821, jc.reijneveld@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary 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). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2008.