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 should contact the research team at the hospital that has recruited you to the study. This is most likely to be your treating physician and / or trial research nurse. 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?

 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.

 Your NHS hospital will collect information from you and/or your medical records for this research study in accordance with our instructions.

Your NHS hospital will use your name, NHS number, and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from the Walton Centre NHS Foundation Trust (Walton Centre), the University of Liverpool and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Your NHS hospital will pass these details to the University of Liverpool and the Walton Centre along with the information collected from you and/or your medical records. The only people in The Walton Centre or the University of Liverpool who will have access to information that identifies you will be people who need to confirm your participation in the study, contact you in relation to Quality of Life Questionnaires or audit the data collection process; as well as share information with NHS Digital and Secure Anonymised Information Linkage (SAIL) Databank for the purpose of the health economic cost analysis. The people who analyse the information will not attempt to identify you or find out your name, NHS number or contact details.

Your NHS hospital will keep identifiable information about you from this study for 25 years after the study has finished.

The Walton Centre and the University of Liverpool will share information about you for this research study with NHS Digital and SAIL Databank. This information will include your name, NHS number, Date of Birth and health information, which is regarded as a special category of information. We will use this information to access the health economic cost of managing your condition. 

At the end of the initial period specified in the Data Sharing Agreement, request will be made to NHS Digital for archiving the data at Bangor University for a period of 15 years in accordance with the clinical trial regulations.

When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.

This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.

The University of Liverpool and the Walton Centre have no intention to transfer personal data to any third countries or international organisations at present. However, anonymous trial data sets are often used for a variety of research projects.

Participant Opt-out letter

How we use your information

The University of Liverpool, the Walton Centre NHS Foundation Trust, and Bangor University are identified as the trial Joint Data Controllers (JDCs). Trial JDCs take great care to abide by our legal and moral obligations when handling your personal and healthcare data. Due to changes introduced in the EU General Data Protection Regulation (GDPR), we would like to provide you with information on the lawful basis on which we are processing your data. The lawful basis for the processing of your personal data for the research study which you have participated in is for “ the performance of a task carried out in the public interest” in line with GDPR Article 6 (1) (e) and Article 9(2)(j). 

As publicly funded organisations the University of Liverpool, the Walton Centre NHS Foundation Trust, and Bangor University use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisations, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research.  This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Health and care research, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.

More information about GDPR and what it means can be found here:

ICO website:

HRA website:

Your information could be used for research in any aspect of health or care, and could be combined with information about you from other sources held by researchers, the NHS or government. 

Where this information could identify you, the information will be held securely with strict arrangements about who can access the information. The information will only be used for the purpose of health and care research, or to contact you about future opportunities to participate in research. It will not be used to make decisions about future services available to you, such as insurance.

Where there is a risk that you can be identified your data will only be used in research that has been independently reviewed by an ethics committee.

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO) ( or call the ICO helpline on 0303 123 1113.

The Data Protection Officers for this study and their contact details are listed below:

Daniel Howarth, University of Liverpool:

Carol Johnson, The Walton Centre NHS Foundation Trust:

Gwenan Hine, Bangor University:

GDPR Transparency Wording

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,W and NI)
Patient Information Sheet (Legal Representative Scotland)


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