| NCT ID | NCT03048084 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Leiden University Medical Center |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2018-02-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2018-02-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studies supporting the use of one specific anticonvulsant in glioma patients. The overall aim of this randomized controlled trial is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure.
Eligibility Criteria
Inclusion Criteria: * Histologically proven or suspected diffuse astrocytoma (Isocytrate Dehydrogenase-1 (IDH-1) wildtype or IDH-1 mutated), diffuse oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), anaplastic astrocytoma (IDH-1 wildtype or IDH-1 mutated), anaplastic oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), glioblastoma (IDH-1 wild-type or IDH-1 mutated), or diffuse astrocytoma not otherwise specified (NOS), anaplastic astrocytoma NOS, oligodendroglioma NOS, oligoastrocytoma NOS, anaplastic oligoastrocytoma NOS, anaplastic oligodendroglioma NOS or glioblastoma NOS. * 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: * Previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks * History of non-brain tumor related epilepsy * Pregnancy * Presence of contra-indications for use of levetiracetam or valproic acid
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03048084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03048084 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03048084 currently recruiting?
Yes, NCT03048084 is actively recruiting participants. Contact the research team at j.a.f.koekkoek@lumc.nl for enrollment information.
Where is the NCT03048084 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Enschede, Netherlands, Leiden, Netherlands, Rotterdam, Netherlands and 1 additional location.
Who is sponsoring the NCT03048084 clinical trial?
NCT03048084 is sponsored by Leiden University Medical Center. The trial plans to enroll 120 participants.