Objectives There is no consensus regarding the need for prophylactic anti-epileptic drug (AED) in seizure-naive newly-diagnosed glioma patients. Data regarding prophylactic AED use are scant and inconclusive from older, small studies that enrolled patients with brain metastases, benign tumours and gliomas. A definitive randomised controlled trial (RCT) is needed to determine whether the policy of prophylactic AED therapy reduces the risk of first seizures in this population.
Design Multi-centre RCT.
Subjects Inclusion criteria: i. seizure-naive, ii. supratentorial glioma suitable for surgery (biopsy/resection), iii. age ≥16 years; iv. Karnofsky performance status >60.
Methods Patients are randomised 1:1. Levetiracetam 500 mg bd for 2 weeks, increased to 750 mg bd thereafter for 1 year. Non-blinded. No placebo. Primary Outcome: one year risk of first seizure. Secondary outcomes: time to first seizure, time to first tonic-clonic seizure, mood, fatigue, quality of life, progression free survival, overall survival and incremental cost per QALY. Estimate of 1 year seizure rate in glioma after surgery is 20%. Based on a reduction in seizure rate to 10% a total of 806 patients will be recruited.
Results Grant awarded by NIHR. Feasibility questionnaire demonstrated prophylactic AED rarely used. Neurosurgeons willing to randomise. 15 UK centres have expressed interest in participating.
Conclusions SPRING will establish class I evidence for the use of seizure prophylaxis in glioma surgery. The trial will open to recruitment in January 2019.
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