Surgeons Trial Of Prophylaxis for Epilepsy in seizure naïve patients with Meningioma: a randomised controlled trial (STOP’EM) (STOP'EM)

Research summary

Meningioma is the commonest primary brain tumour. 1600 patients/year have surgery in the UK. At diagnosis,70% of patients will not have had seizures,but ~12% of the seizure-naïve patients will have a seizure within 12 months of surgery. Seizures impact quality of life and can be life-threatening. Side effects from anti-epileptic drugs (AED) also affect quality of life. Neurosurgeons administer prophylactic AEDs to prevent seizures despite a lack of evidence to support this. A meta-analysis of RCTs in brain tumours suggests that older AED may prevent seizures in the first week after surgery but not thereafter. There are no studies assessing newer AEDs in the prophylactic setting. Aims & objectives Primary objective: 1. To determine whether 2 weeks prophylactic levetiracetam treatment reduces the risk of developing seizures within 12 months of surgical resection of newly-diagnosed seizure naïve meningioma compared to placebo Secondary objectives: 2. To improve the understanding of the safety of prophylactic levetiracetam 3. To determine whether prophylactic levetiracetam influences quality of life 4. To determine the 30-day morbidity and mortality associated with meningioma surgery Economic objective: 5. To estimate the cost effectiveness of prophylactic levetiracetam in seizure-naïve meningioma Exploratory/ Translational objective: 6. To create a repository of MRI scans and blood samples for future research,investigating imaging and blood biomarkers that may predict seizure development Methods Health technology assessed; 1:1 randomisation: •Intervention: 14 days levetiracetam 500mg bd started one day before surgery •Comparator: placebo Design: multi-centre,double-blind RCT Setting: 20 UK neurosurgery units Population: seizure-naïve meningioma undergoing surgery Inclusion Criteria: 1. Newly-diagnosed meningioma on MRI 2. Seizure-naïve at presentation 3. Surgical resection of meningioma planned 4. Age ≥16 years 5. Written informed consent Exclusion Criteria: 1. Posterior fossa meningioma 2. Previous history of epilepsy 3. Previous history of provoked seizures 4. Previous cranial neurosurgery for any cause 5. Renal failure (Chronic Kidney Disease [CKD] 4-5) 6. Use of anti-epileptic drug for another indication (e.g. trigeminal neuralgia) within 7 days preceding randomisation 7. Known hypersensitivity to levetiracetam,other pyrrolidone derivatives or any of the excipients 8. Actively breastfeeding 9. Weigh below 50kg (if aged 16 or 17 years)

Principal Investigator

Dr Sanjeeva Jayaretna

Contact us

Email: dendron@ouh.nhs.uk

IRAS number

1005506