Seizure Treatment in Glioma (STING): Comparing a Treatment Strategy with Levetiracetam Versus Treatment with Valproic Acid in Glioma Patients with a First Seizure

Who is this study for? Patients with Glioma
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam UMC
SUSPENDED
Amsterdam
Medisch Spectrum Twente
RECRUITING
Enschede
Leiden University Medical Center
RECRUITING
Leiden
Erasmus Medical Center
RECRUITING
Rotterdam
Haaglanden Medical Center
RECRUITING
The Hague
Contact Information
Primary
Johan AF Koekkoek, MD, PhD
j.a.f.koekkoek@lumc.nl
0031715269111
Backup
Monique Baas
baas@lumc.nl
0031715297012
Time Frame
Start Date: 2018-02-01
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 120
Treatments
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Amsterdam UMC, location VUmc, Medical Center Haaglanden, Erasmus Medical Center
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov

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