A randomised controlled trial assessing the safety and effectiveness of perampanel, an anti-epileptic drug, in people with brain tumours.
About this study
A new anti-epileptic drug, called perampanel shows promise for being able to control and prevent seizures in patients with brain tumours. There are two separate studies in this project for patients with gliomas, a type of brain tumour.
Study 1 is for patients who experienced a preoperative seizure. In this study, we will compare perampanel and levetiracetam treatment over 12 months after brain tumour surgery.
Study 2 is for patients who did not experience a preoperative seizure. In study 2 we will compare perampanel and placebo for 4 months after brain tumour surgery and then observe participants for a further 8 months.
Anticipated enrolment close date: 31 March 2019
Who can take part
- People aged 18 to 65 years; and
- With a diagnosis of brain tumour (grade II-III glioma) on MRI; and
- With a planned upcoming neurosurgical operation (resection or biopsy)
Before the operation all participants will receive a high-quality MRI at Melbourne Brain Centre Imaging Unit, The University of Melbourne. Blood, urine and saliva samples will also be taken on a single occasion.
At the time of your operation, we would also like to test a small sample of brain from next to your tumour which will be safely taken by your neurosurgeon. No extra brain tissue will be removed by your neurosurgeon for this research project during the operation other than that tissue they were intending to remove anyway.
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.