A study comparing two anti-epileptic drugs in glioma patients with a first seizure

Seizure Treatment IN Glioma (STING): comparing a treatment strategy with levetiracetam versus treatment with valproic acid in glioma patients with a first seizure

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22812

Enrollment

120

Registered

2017-01-02

Start date

2017-09-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma patients with a first epileptic seizure

Interventions

Treatment with (A) levetriacetam, or (B) valproic acid

Eligibility

Inclusion 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: ¡Ý18 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

Exclusion criteria: - Previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks - History of non-brain tumor related epilepsy - Pregnancy - History of a status epilepticus - Presence of contra-indications for use of levetiracetam or valproic acid

Design outcomes

Primary

Measure	Time frame
the percentage of patients with ongoing seizure freedom at 6 months	—

Secondary

Measure	Time frame
- time to 6 month seizure freedom - seizure outcome at 12 months - level of toxicity and hospitalization rate due to treatment failure - impact of seizures on HRQoL, cognitive complaints, anxiety/depression and performance status - burden of epilepsy - treatment response (e.g., maximum dosage of AED, use of add-on AED). - progression-free and overall survival - burden of epilepsy - treatment response (e.g., maximum dosage of anti-epileptic drug, use of add-on anti-epileptic drug). - progression-free and overall survival	—

Measure

Time frame

- time to 6 month seizure freedom - seizure outcome at 12 months - level of toxicity and hospitalization rate due to treatment failure - impact of seizures on HRQoL, cognitive complaints, anxiety/depression and performance status - burden of epilepsy - treatment response (e.g., maximum dosage of AED, use of add-on AED). - progression-free and overall survival - burden of epilepsy - treatment response (e.g., maximum dosage of anti-epileptic drug, use of add-on anti-epileptic drug). - progression-free and overall survival

—

Contacts

Public ContactLinda Dirven

Department of Neurology, Leiden University Medical Center

l.dirven@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)