Withdrawal of antiepileptic drugs in low grade and anaplastic glioma patients after long-term seizure freedom

Withdrawal of antiepileptic drugs in low grade and anaplastic glioma patients after long-term seizure freedom - Withdrawal of AEDs in glioma patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41523

Enrollment

Registered

2013-11-25

Start date

2014-01-27

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Epilepsy in brain tumour patients

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) adults (>18 years) (2) histologically confirmed LGG or anaplastic glioma (WHO grade I pilocytic astrocytoma, pleomorphic xanthoastrocytoma, subependymal giant cell astrocytoma, and subependymoma; WHO grade II astrocytoma , mixed oligo-astrocytoma, oligodendroglioma; ependymoma; WHO grade III brain tumours (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligo-astrocytoma or anaplastic ependymoma)) (3) presence of epilepsy and treatment with AEDs (4) past anti-tumour treatment (surgical resection, brain irradiation or temozolomide chemotherapy) (5) stable disease with absence of clinical or radiological signs of tumour recurrence during the past year (6) seizure freedom for at least 1 year counted from the date of first surgery, last day of first irradiation or last day of first temozolomide chemotherapy cycle; OR seizure freedom for at least 2 years from the last non-acute symptomatic post-therapy seizure.

Exclusion criteria

Exclusion criteria: Patients who underwent biopsy only.

Design outcomes

Primary

Measure	Time frame
Study parameters include: - physician*s decision and decision related arguments to continue AEDs despite fulfillment of all in- and exclusion criteria - shared decision on AED continuation or withdrawal and decision related arguments - start date of AED withdrawal, point of complete AED withdrawal, changes in AED type or dose (where applicable) - seizure recurrence - tumour symptoms, additional anti-tumour treatment and tumour recurrence - treatment related adverse effects.	—

Measure

Time frame

Study parameters include: - physician*s decision and decision related arguments to continue AEDs despite fulfillment of all in- and exclusion criteria - shared decision on AED continuation or withdrawal and decision related arguments - start date of AED withdrawal, point of complete AED withdrawal, changes in AED type or dose (where applicable) - seizure recurrence - tumour symptoms, additional anti-tumour treatment and tumour recurrence - treatment related adverse effects.

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Countries

Netherlands

Outcome results