Surgeons Trial Of Prophylaxis for Epilepsy in seizure naïve patients with Meningioma: a randomised controlled trial (STOP’EM)
Description: Context: This is a study aiming to help adults diagnosed with a meningioma brain tumour that needs surgical removal and who have not had a seizure beforehand. We want to know whether a short course of an anti-epileptic drug (AED) started 1 day before surgery will prevent seizures happening after surgery. Meningiomas are the most common type of primary brain tumour. They grow from the lining of the brain. Most meningiomas are non-malignant, can be removed with surgery and do not regrow. In the UK each year, about 1600 people with a meningioma have surgery. Approximately 70% of people with meningiomas do not present with epileptic seizures, but following surgical removal around 12% will have a seizure within the first 12 months. Seizures affect people’s quality of life in many ways and lead to uncertainty about the future. They cause anxiety and social stigma, affect activities of daily living, cause a loss of independence, including loss of driving license, and can threaten life. In patients who have never had a seizure, neurosurgeons don’t know whether giving an AED before surgery (known as prophylaxis) will prevent seizures. In the UK and internationally, some neurosurgeons use prophylaxis and others do not. Previous studies have not shown conclusive results and were done using older drugs with worse side effects. What this study does: This study will compare a newer, but well-established anti-epileptic drug called levetiracetam, to a placebo (a capsule that looks the same but has no active drug in it), and will determine: 1) Whether starting levetiracetam shortly before surgery (as a preventative measure) reduces the chance of developing a seizure in the first 12 months after surgery 2) Whether starting levetiracetam shortly before surgery (as a preventative measure) allows more people to resume driving at 6 and 12 months after surgery 3) The quality of life in patients undergoing surgery for meningioma 4) Whether the prophylactic use of levetiracetam is cost effective Where this study will open: 20 neurosurgery units in the UK. Who can take part: Adults who have a meningioma that needs surgical removal and who have not had a seizure beforehand, can take part. We will recruit 1004 patients. How will the trial work: Participants will be assigned at random to one of two groups: Group 1: levetiracetam (500mg morning & night: started 1 day before surgery & continued for 14 days) Group 2: placebo (started 1 day before surgery & continued for 14 days) Participants will follow the normal care pathway and will be seen in clinic after surgery at 2-6 weeks, 3 and 12 months, as well as having a telephone consultation at 6 & 9 months. Participants will complete quality of life questionnaires before surgery and at 12 months. Participants will be followed up for a total of 12 months.
Amount: £1,642,000
Funding type: research
Funder scheme: Health Technology Assessment
Start date: 2021-10-01
End date: 2027-09-30
Investigator: Michael Jenkinson
Institution: University of Liverpool
Funded outputs count: 12
Funder award ID: NIHR129748
OpenAlex ID: G4862945173