SPRING

Trial Info

Status: Open

Specialty: Brain

Date Opened: 29/10/2021

Planned Close Date: unknown?

Sponsor: Public Health Scotland

Principal Investigator: Mr Isaac Phang

Study Title: SPRING - Seizure PRophylaxis IN Glioma

The most common type of primary brain tumour is called a cerebral glioma; around 6000 new cases are reported in

the UK each year. 20% of patients who are suspected to have this type of tumour will develop seizures which need to

be treated with anti-epileptic drugs before surgery. Of the remaining patients who go on to have surgery 30-50% will

develop seizures and need to take anti-epileptic drugs post-surgery or later on.

People with a tumour that have had a seizure are given an anti-epileptic drug (AED). It is unclear if patients who have

never had a seizure should be given an AED to prevent them occurring. Currently in the UK, some doctors prescribe

AEDs to patients before surgery, whilst others do not. We need to find out whether an AED is needed, and at what

dose, so that we can give up to date evidence based guidance to neuro-surgeons and patients and provide the best

treatment for patients.

This is a two arm study, patients will be randomly allocated on a 1:1 basis either Levetiracetam or no anti epileptic

treatment.

1)Patients with suspected cerebral glioma on MRI

2)Capable of giving informed consent

3)Patients must be ≥ 16 years old

4)Patients must have a Karnofsky performance status ≥70

5)Patients must be able to safely swallow pills

6)Planned surgery for presumed glioma (biopsy or resection)

1)Pregnant

2)History of any type of seizure for at least 10 years prior to randomisation 3)Known Severe Chronic Kidney Disease

(CKD4 - eGFR < 30ml/min)

4)Concomitant methotrexate

5)Concomitant AED (including use for other reasons (e.g. pain))

6)Concomitant benzodiazepines

7)Hypersensitivity to levetiracetam

Lead Research Nurse: Mr Allan Brown (x2031) Allan.Brown@lthtr.nhs.uk

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