STOP’EM is a study for adults with a meningioma that needs surgical removal and who have not had a seizure before. We want to know if a short course of an anti-seizure medication (ASM) started 1 day before surgery prevents seizures happening after surgery.

Meningioma are the commonest primary brain tumour. They grow from the lining of the brain. In the UK each year about 1600 people with a meningioma have surgery. Approximately 70% of people do not present with epileptic seizures, but after within 12 months of surgical removal, around 1 in 8 people (12%) will have an epileptic seizure for the first time. Seizures affect quality of life & lead to uncertainty about the future.

In patients who have never had a seizure, neurosurgeons do not know whether giving an ASM before surgery (prophylaxis) will prevent seizures. Some neurosurgeons use prophylaxis & others do not.

STOP’EM will compare a well-established ASM called levetiracetam, to a placebo (a capsule that looks the same but contains no active drug). STOP’EM will look at whether starting levetiracetam shortly before surgery as a preventative measure:

1. reduces the chance of having a seizure in the 12 months after surgery

2. allows more people to resume driving 12 months after surgery

3. affects the quality of life in patients

4. is cost-effective

Participants will be assigned at random to either:

Group 1: levetiracetam for 14 days

Group 2: placebo for 14 days

Participants will follow the normal care pathway and will be followed up regularly for 12 months to assess if they develop seizures, and to measure their quality of life.

• STOP’EM Participant Information Sheet.

Patients with the following characteristics will be eligible for inclusion in the trial:

• 1. Newly-diagnosed meningioma on MRI
• 2. Seizure-naïve at presentations
• 3. Surgical resection of meningioma planned
• 4. Age ≥16 years
• 5. Written and informed consent

Patients with the following characteristics will be excluded from the trial:

• 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] 3-5)
• 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)

STOPEM FAQs for Sites.