What is the purpose of the study?

The aim of the SPRING trial is to find out if giving patients with a suspected primary brain tumour (cerebral glioma), who have never had a seizure, an anti-epileptic drug (levetiracetam) before surgery to see if it will help prevent them from developing seizures. This will help us to give neurosurgeons in the UK the best advice about how to treat patients with a cerebral glioma.

Why have I been chosen?

You have been invited to take part in this study because you are likely to have a cerebral glioma and you would be suitable to take part in the SPRING study.

What will happen to me if I take part?

If you decide you would like to take part in the study you will have a series of tests and examinations to confirm that you are eligible.

Sometimes we don’t know which treatment is best for patients. To find out, we need to compare different treatments. We put people into groups and give each group a different treatment. The results are compared to see if one is better. To try to make sure the groups are the same to start with, each patient is put into a group by chance (randomly). In this study there are two groups.

The first group will receive an anti-epileptic drug called levetiracetam at a dose of 1500mg daily. The second group will receive no anti-epileptic drug; this is currently normal practice. At each visit we will ask you to complete some short questionnaires about your health, we estimate that the time taken to complete them will be less than twenty minutes.

What are the side effects of any treatment received when taking part?

Levetiracetam is a commonly prescribed anti-epileptic drug. No one can predict if you will have any of the side effects or how they may affect you. If you find you are suffering from any side effects it is very important to tell the study nurse or doctor at your next visit. If the side effects are serious or concerning you, please call the study team on the number provided on your patient card. The side effects can be:

• Most common (affecting more than 1 in 10 people) side effects at varied levels of severity are: sleepiness, headache, and running/blocked nose.
• More common (Affecting between 1 in 10 and 1 in 100 people) side effects at varied level of severity are: off food, low mood or changes in behaviour, anxiety, poor sleep, dizziness, gastrointestinal symptoms (indigestion, loose stools)

What are the possible benefits of taking part?

If you do wish to participate in this study we cannot be sure that there will be a direct benefit to the patients in the trial. We hope to be able to find out if taking levetiracetam before surgery will have any effect on delaying, stopping or altering the severity of any seizure that happens after the surgery. If you are allocated levetiracetam we might expect a lower risk of developing seizures, although the size of this effect is as yet unknown. The results of the trial will hopefully allow us to provide the best advice on preventing seizures in patients with suspected cerebral glioma.