Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2018-02-01
2028-07-01
Brief Summary
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Detailed Description
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Levetiracetam and valproic acid are the most commonly used AEDs in glioma patients. Both drugs are used for the treatment of seizures, have similar toxicity profiles and are non-enzyme inducing AEDs, therefore not interfering with chemotherapeutic drugs. However, it is not known whether one drug is more effective than the other in reducing seizures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Levetiracetam
Patients in this treatment arm will receive levetiracetam monotherapy. The dosage depends on the specific treatment step, as indicated in the protocol. In step 1, patients will receive 2x500 mg/d levetiracetam in the form of tablets. In step 2, dosage is increased to 1x250 plus 1x500 mg/d and in step 3 to 2x1000 mg/d levetiracetam. In step 4, levetiracetam is increased to 2x1500mg/d. In the fifth treatment step, patients will receive 2x1500 mg/d levetiracetam, and another AED will be added. The type and dosage of this add-on AED is according to the physician's preference, but in line with current clinical practice in the Netherlands.
Levetiracetam
Antiepileptic drug levetiracetam
Valproic acid
Patients in this treatment arm will receive valproic acid monotherapy. The dosage depends on the specific treatment step, as indicated in the protocol. In step 1, patients will receive 2x500 mg/d valproic acid in the form of tablets. In step 2, dosage is increased to 1x250 plus 1x500 mg/d and in step 3 to 2x1000 mg/d valproic acid. In step 4, valproic acid dosage is increased to a maximum of 2x1250mg/d. In the fifth treatment step, patients will receive 2x1250mg valproic acid, and another AED will be added. The type and dosage of this add-on AED is according to the physician's preference, but in line with current clinical practice in the Netherlands.
Valproic Acid
Antiepileptic drug valproic acid
Interventions
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Levetiracetam
Antiepileptic drug levetiracetam
Valproic Acid
Antiepileptic drug valproic acid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult patients: ≥18 years of age
* First epileptic seizure, no longer than 2 weeks ago
* Monotherapy with antiepileptic drugs is considered most appropriate at the time of randomization
* Willing to provide written informed consent
Exclusion Criteria
* History of non-brain tumor related epilepsy
* Pregnancy
* Presence of contra-indications for use of levetiracetam or valproic acid
18 Years
ALL
No
Sponsors
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Medical Center Haaglanden
OTHER
Erasmus Medical Center
OTHER
Amsterdam UMC, location VUmc
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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j.a.f.koekkoek
MD PhD
Locations
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Amsterdam UMC
Amsterdam, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Haaglanden Medical Center
The Hague, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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van der Meer PB, Taphoorn MJB, Koekkoek JAF. Management of epilepsy in brain tumor patients. Curr Opin Oncol. 2022 Nov 1;34(6):685-690. doi: 10.1097/CCO.0000000000000876. Epub 2022 Jul 16.
Lang F, Liu Y, Chou FJ, Yang C. Genotoxic therapy and resistance mechanism in gliomas. Pharmacol Ther. 2021 Dec;228:107922. doi: 10.1016/j.pharmthera.2021.107922. Epub 2021 Jun 23.
Other Identifiers
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77353
Identifier Type: -
Identifier Source: org_study_id
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