Trial Summary

Changing Agendas on Sleep, Treatment and Learning in Childhood Epilepsy.

Background

Rolandic epilepsy is the most common type of epilepsy. It is also known as 'benign rolandic epilepsy', 'benign childhood epilepsy' or 'benign childhood epilepsy with centrotemporal spikes'. Children with rolandic epilepsy have seizures and can often find that their learning, sleep, behaviour, self-esteem and mood are sometimes affected.

What is the CASTLE?

CASTLE is a research study that aims to find out the best way to treat children with rolandic epilepsy. The study compares three treatment options: Carbamazepine, levetiracetam, or no antiepileptic medicine. In addition, the study also compares a sleep training plan with standard care (no sleeping plan) to see if this helps with seizures.

Why are we doing this study?

We are doing the CASTLE study to find out which is the best medicine to give children and young people who have rolandic epilepsy. We also want to find out if better sleep helps with rolandic epilepsy.

What's involved if I agree to take part?

Your child will participate in the study for at least 12 months, during which we will collect information at your routine medical appointments. At these visits you and your child will be asked to complete paper questionnaires, your child will be asked to complete learning games on an iPad and the research team will ask questions to see how you and your child are getting on with the seizures and treatment.

How will I know which treatment my child will be on?

In research we often split study participants into groups to study how different treatments work. Participants in one group will receive different treatment to participants in another. In CASTLE there are three treatment groups:

  • Group A - carbamazepine
  • Group B - levetiracetam
  • Group C - no medicine

Once your child has been allocated to a treatment group, they will also be assigned to one of the following sleep groups:

  • Group 1 - Patients follow the sleep training plan
  • Group 2- Standard care (patients don't follow the sleep training plan)
For example, your child could be allocated to groups A and 2.

It is really important that each group in the CASTLE study has a similar mix of patients in it so we know that if one group of patients does better than the other it is very likely to be because of the treatment and/or sleep training plan and not because there are differences in the types of patients in each group.

To do this, we use a computer programme that puts patients 'at random' into one of the groups for both the treatment and the sleep training – you might hear this described as 'randomisation' or 'random allocation', but they all mean the same thing. Neither you nor your child's doctor choose which group your child is in.

Where is CASTLE up to?

CASTLE has received all necessary initial approvals (ethical, MHRA and HRA) for the study to go ahead. We intend to begin recruitment in June.

Recruiting Centres

Open Sites
  1. No sites open at this time
Randomised patients
0
Target patients
330
Open site
0
Target Sites
60

Collaborators

King's celllege Hospital NHS Logo
CTRC Logo
King's celllege London Logo
University of Liverpool Logo
Oxford Brookes University Logo
Edge Hill University Logo
Bangor University Logo

Hospital departments taking part

The study will take part in NHS out-patient paediatric epilepsy and general paediatric clinics across the UK. To see if your hospital is taking part please visit the list of open sites in recruiting centres.

Study funder

This study has been funded by the National Institute for Health Research.

Study organiser

The study is sponsored by King's College London & King's College Hospital NHS Foundation Trust and coordinated by the Clinical Trials Research Centre at the University of Liverpool. Other organisations such as Bangor University, Oxford Brookes University and Edge Hill University also collaborate in the CASTLE study.

Study review and approval

The study has been reviewed by a research ethics committee, who have agreed the study is being conducted in a correct and appropriate manner. The study has also been approved by the Medicines & Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA).

Your Information

How will we use your information:

As a university and NHS organisation, King's College London (KCL) and King's College Hospital NHS Foundation Trust (KCH) 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 should serve the public interest, 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.

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).

KCH & KCL data protection officers:

The Data Protection Officers for King's College London can be contacted at kch-tr.dpo@nhs.net

The Data Protection Officer for King's College Hospitals NHS Foundation Trust is Albert Chan and you can contact them at info-compliance@kcl.ac.uk

NHS Digital and NHS hospital finance data

We will also collect information about your child for this research study from NHS Digital and your child's NHS hospital finance department. CTRC will have to send identifiable information from your child such as date of birth/ NHS Number/ postcode /signed consent form to these bodies so the records can be located. The collected data from both sources, which is regarded as a special category of information, will only have your child's CASTLE study number attached to it and no other personal identifiable information. We will use this information to measure the use of health services.

Future research

When you agree for your child to take part in a research study, the information about your child's 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 child's 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.

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

Where this information could identify your child, 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 your child about future opportunities to participate in research. It will not be used to make decisions about future services available to your child, such as insurance.

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

CANTAB data

When your child completes the iPad game, data will be securely uploaded to a cloud (online backup) where only authorised CASTLE members from CTRC and software developers can access the pseudonymised information. Software developers include the company who owns the CANTAB software (Cambridge Cognition Limited) and their sub-processors (Armor Defense, Inc.; Amazon Web Services, Inc.; Amazon Web Services EMEA SARL; and Cambridge Cognition LLC).

Contact

Email: castle.rct@liverpool.ac.uk
Clinical Trials Research Centre
2nd Floor – Institute in the Park
Alder Hey Children's NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
+44 (0)151 795 8774