A large clinical trial is testing whether giving patients a daily anti-epileptic drug before surgery for a suspected brain tumour can prevent their first seizure. Around a quarter of people with glioma—a type of brain cancer—will eventually have a seizure, often with serious consequences such as falls, hospitalisation, and delayed treatment. Currently, doctors have no clear evidence on whether to prescribe preventive anti-epileptic drugs to patients who have never had a seizure. This trial directly addresses that uncertainty. If the drug, levetiracetam, proves effective, it could change standard care for newly diagnosed glioma patients. Preventing seizures would reduce emergency hospital visits, improve quality of life, and allow patients to focus on their cancer treatment without the added trauma of a sudden seizure. If the drug shows no benefit, the trial will spare thousands of patients unnecessary side effects and medication costs each year. Either result will give surgeons and oncologists a firm evidence base for a decision that currently rests on guesswork.
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Design: Two arm, multicentre randomised trial of prophylactic anti-epileptic drug (Levetiracetam) versus no anti-epileptic drug (AED) (comparator) in patients with suspected cerebral glioma. Randomly assigned - 1:1 basis Inclusion / Exclusion Criteria Inclusion 1) Suspected cerebral glioma on CT/MRI 2) Age >/= 16 years 3) Karnofsky Performance Status of > 60 4) Able to swallow pills safely 5) Capable of giving informed consent Note – In Chronic Kidney Disease stage 3 (eGFR 30-59 mL/min/1.73m2) (250mg PO twice daily will be given for 2 weeks, then increasing to a maximum of 500mg PO twice daily for a year.. Exclusion 1) Pregnant 2) History of any seizure in the last 10 years 3) Known Severe Chronic Kidney Disease (CKD4 -– eGFR < 30ml/min/1.73m2) 4) Concomitant methotrexate 5) Concomitant AED for other reasons (e.g. pain) 6) Hypersensitivity to Levetiracetam Target Population: Seizure-naïve adults with newly diagnosed suspected glioma where surgery is planned. Health Technologies Being Assessed: Intervention: Pre-operative prophylactic Levetiracetam 500mg PO twice daily for two weeks, then 750mg twice daily thereafter, for one year. (In patients with CKD3, 250mg PO twice daily for 2 weeks, then increasing to a maximum of 500mg PO twice daily for one year). Comparator: No AED. Sample Size: 806 patients. Project timetables including recruitment rate: Project Timetable is a total 65 months (5.42 years) - commencing Apr 2018 • Trial start up (9 months) – Apr 2018 – Dec 2018 • Pilot study (12 months) – Jan 2019 – Dec 2019 • 1 month to review pilot study – Jan 2020 • Recruitment period (24 months) – Feb 2020 – Jan 2022 • Follow-up (12 months) – Feb 2022 – Jan 2023 • Trial close down (6 months) – Feb 2023 – Jul 2023 Recruitment Rate: Estimates from pilot sites suggest that the study would recruit over 989 patients in a 3 year period. Expertise in Team: The core team includes Neurologists, Neurosurgeon, Health Economists, Oncologist, PPI representatives and a clinical trials unit. Please refer to ‘Strengths of Research Team’.
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