Is SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy correlated with their clinical response to levetiracetam?
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the total number of seizures during the study
period, which is 6 months for every indivicual patient.
Secondary outcome
The secondary study parameters will be time to drug withdrawal due to
inadequate seizure control (if applicable). Other study parameters will be
change in cognitive function, quality of life, and brain activity as measured
by MEG at the end of the study, compared with baseline.
Background summary
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. Better selection of glioma patients with seizures for
treatment with levetiracetam would avoid unnecessary and ineffective treatment
with levetiracetam. Recently the synaptic vesicle protein 2A (SV2A) has been
demonstrated to be the binding site for levetiracetam. It is suggested that the
expression of 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.
Study objective
Is SV2A expression in surgically removed tumour and tumour-surrounding tissue
of glioma patients suffering from epilepsy correlated with their clinical
response to levetiracetam?
Study design
Multi-centre observational cohort study.
Study burden and risks
The burden associated with participation consists of 1) a number of extra
visits to the outpatients* department (at least at the time of inclusion, at 3
months, and at the end of the study (6 months)), 2) completing questionnaires
regarding quality of life at the start and at the end of the study, 3) keeping
a diary regarding the frequency and severity of epileptic seizures during 6
months, 4) a neuropsychological test battery at the start and at the end of the
study, 5) examination through magnetoencephalography (MEG) at the start and at
the end of the study (only for patients included at the VUmc), 6) blood
sampling at the start and the end of the study. The risks associated with
participation are minimal as levetiracetam is registered for monotherapy in
patients with focal epileptic seizures, whether or not with secondary
generalisation, which is the type of seizures glioma patients suffer from. If
patients that are included into this observational study turn out to be
refractory to treatment with levetiracetam during the study interval, patients
will be converted to treatment with another AED, conform national and
international guidelines on prophylaxis and treatment of epilepsy. This will be
regarded as drug withdrawal due to inadequate seizure control. In our view, the
burden and risks associated with participation are proportionate to the
potential value of the research for the future treatment of glioma patients
suffering from epilepsy. Ultimately, the results of this study could lead to
better selection of glioma patients for treatment with levetiracetam, thereby
avoiding unnecessary treatment in other glioma patients.
Postbus 7057
1007 MB Amsterdam
Nederland
Postbus 7057
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
We will include adult (> 18 years) glioma patients who suffered 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.
Exclusion criteria
Patients who do not have a basic proficiency of the Dutch language, or are unable to communicate adequately (e.g. due to dysphasia) will be excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15305.029.06 |