STOP'EM

• Research type

  Research Study

• Full title

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

• IRAS ID

  1005506

• Contact name

  Michael Jenkinson

• Contact email

  michael.jenkinson@liv.ac.uk

• Sponsor organisation

  University of Liverpool

• Eudract number

  2022-002371-10

• ISRCTN Number

  ISRCTN14381346

• Research summary

  STOP’EM is a study for adults with a meningioma that needs surgical removal & who have not had a seizure before. We want to know if a short course of an anti-epileptic drug (AED) 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 surgical removal, around 12% will have a seizure within 12 months. Seizures affect quality of life & lead to uncertainty about the future.
  In patients who have never had a seizure, neurosurgeons don’t know whether giving an AED before surgery (prophylaxis) will prevent seizures. Some neurosurgeons use prophylaxis & others don’t.
  STOP’EM will compare a well-established AED 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

  The study is funded by National Institute for Health Research & will open in 20 neurosurgery units (UK/Ireland).
  Adults who have a meningioma that needs surgical removal & who haven’t had a seizure before can take part. We will recruit 1004 patients. Patients 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 & will be followed up regularly for 12 months to assess if they develop seizures & to measure their quality of life.

• REC name

  London - Central Research Ethics Committee

• REC reference

  22/LO/0868

• Date of REC Opinion

  25 Apr 2023

• REC opinion

  Further Information Favourable Opinion