Epilepsy is a common neurological (brain) disorder. Approximately 2-3% of the population will be given a diagnosis of epilepsy by time they reach 60.
A number of new drugs have been approved to treat epilepsy in the UK in the past few years. These drugs have been shown in research studies to prevent seizures and to be safe. There is as yet, however, no good evidence as to whether they are better at treating epileptic seizures or safer than the standard drugs that have been used for many years.
In this research study – called SANAD-II – we will compare the standard and new antiepileptic drugs to identify which drugs are the most effective and which ones make the best use of NHS resources.

Frequently asked questions
More information can be found in the Patient Information sheets at the bottom of the page.

Why have I been invited to take part in this research study?
You have been invited because your doctor has recently diagnosed you as having epilepsy and recommended that you start medication.

What will happen during the study?
Your doctor will decide if you should have any tests or investigations.
You will receive either the standard or one of the new treatment drugs, the treatment you will be offered will be chosen at random (by a computer). Neither you nor your doctor can choose which anti-epileptic medication you will receive. However, once you have been allocated an anti-epileptic medication both you and your doctor will know what it is.
After treatment has been started you will be followed up in clinic, typically at 3, 6 and 12 monthly intervals, as is usual in the NHS, and annually thereafter, depending on how well you are responding to treatment. At the same intervals you will be asked to complete some questionnaires, we would be very grateful if you would complete them and post them back in the provided prepaid envelope. You will also be asked to keep a diary of any seizures that may occur.
The study will start in 2012 and we plan to recruit over 1,500 patients with epilepsy, and we wish to follow up everyone who has taken part in the study until 2018.

What are the side effects of the antiepileptic drugs being tested?
There are side effects to all types of medicines, although all the treatments being assessed in this study have been licensed as being safe and effective for treating people with epilepsy.

What are the benefits of taking part?
Because this is a research study we cannot say if you will benefit directly from it. However, we hope that the results of this study may help us to improve the treatment of epilepsy in the future.

Do I have to take part, and can I change my mind?
Taking part is completely voluntary. If you decide not to take part, or after an original decision to take part you decide to withdraw, from the study, this is OK. You do not have to give a reason and it will not affect the standard of care you receive now or in the future.

Who is doing this research study?
The study is funded by the Department of Health. It is being run in your hospital, and is being organised by the University of Liverpool and the Walton Centre NHS Foundation Trust in Liverpool.

What will happen to my information?

All information collected about you or your child during this study will be confidential and will be handled, stored and destroyed in accordance with the Data Protection Act 1998. All data collected is anonymised and only those working on the study will have access to it.

The aim of SANADII is to compare standard and new anti-epileptic medicines in order to identify which are the most effective in relation to seizure control, quality of life and also NHS resources.  

In order to ensure the data collected for the trial is used in the most effective way, a number of different experts will look at the information collected. The University of Liverpool can look at the anonymised data and see which treatment is the best for seizure control. We will also ask experts at the University of Bangor to review which treatment makes the best use of NHS resources as well as how these treatments affect the patient’s quality of life.

Further information about how the study team will use your information and how you can opt out of this is available here

For more information about this trial please view and download the patient information sheets below:
Patient Information Sheet (Children aged 5-7 years)
Patient Information Sheet (Children aged 8-12 years)
Patient Information Sheet (Children aged 15-17 years)
Patient Information Sheet (For Parents)
Patient Information Sheet (For Adults)
Patient Information Sheet (AWI)
Patient Information Sheet (Legal Representative E,WandNI)
Patient Information Sheet (Legal Representative Scotland)


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