Do you want to help personalise migraine treatment?

Welcome

If you are a migraine patient, we would like to invite you to participate in this research study. Before you decide, it is important that you understand why the research is being done and what it would involve for you. Please take time to read this information, and discuss it with others if you wish. If there is anything not clear or if you would like more information, please don’t hesitate to contact us.

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Am I eligible to participate?

Eligible participants will:

Be between 18 and 60
Live in the United Kingdom
Be taking some form of medication for migraine
Have no history of cluster headaches and trigeminal autonomic cephalgias (TACs), previous stroke (excluding TIA), previous major head injuries or epilepsy

If you are not eligible we would still invite you to sign up to our newsletter to hear about other studies we may have in the future.

What is the purpose of the study?

In this study we are trying to determine if genetic and lifestyle information can be used to improve the decision-making process involved in the prescription of drugs for acute and chronic migraine.

We hope that this could improve the lives of millions around the world who suffer from migraine.

Do I have to take part?

It is up to you to decide whether or not to take part in this voluntary study. If you decide to take part, you are free to withdraw consent at any time without giving a reason. This would not affect your routine clinical care or legal rights. If you decide that you no longer wish to continue with the study, we would still retain any data already obtained from you in an anonymous form.

What will happen to me if I decide to take part?

If you are eligible, we will send you a patient information sheet and a consent form. Once you return the consent form to us, you will be asked to complete the following steps:

You will be sent a short online questionnaire assessing your migraine history.
We will then send a saliva collection tube to your address. Into this tube we will ask you to provide approximately half a teaspoon of saliva and return this to us in the provided prepaid envelope.
After we receive your saliva sample, we will require no further samples from you, nor will you be required to have any follow-ups in person or via questionnaire.
If you have a smartphone and/or a smartwatch you will be asked to download a mobile app from the Google Play or Apple App Store to allow us to gather digital biomarker information (e.g. heart rate, sleeping hours) to optimise your personalised treatment recommendation. We ask you to use this app for 6 months after enrolling in the study.

What should I consider?

We kindly ask you not to drink any alcoholic beverages 24 hours before you provide the saliva sample. There are no further considerations while participating in the study. You can continue to follow your daily routine and take your regular medication or other prescribed or over-the-counter medicines. You can also participate in this study if you are involved in other research studies.

Are there any possible disadvantages or risks from taking part?

It is unlikely that as a participant you will experience any disadvantages or risks from taking part in this study. The study is specifically designed to be non-invasive and will not disrupt your daily routine.

What are the possible benefits of taking part?

By taking part in this study you will be helping us in our research to potentially improve the lives of millions of migraine sufferers worldwide. Should the study be successful at the end of the study, you will receive a preliminary summary of how to potentially improve your current migraine treatment based on our findings. Other than this, there are no direct benefits to taking part in this study.

Will my General Practitioner/family doctor (GP) be informed of my participation?

You will receive a letter that you may take to your GP to inform your doctor of your participation in this study. Due to the non-invasive nature, the study will have no impact on your regular care.

Will my taking part in the study be kept confidential?

Your participation in this study will be kept confidential. All of your personal and contact information will be stored securely, and any data generated from your saliva sample or through the Neurolytic Healthcare App will be stored in a de-identified manner, with your samples being assigned a unique random identifier. This means that any genetic or study data will be stored in a way that makes it impossible to identify you from your data alone.

Will I be reimbursed for taking part?

As there are no travel costs associated with this study, we will compensate you for your time in the form of a voucher for a pharmacogenetic test for migraine treatment at Neurolytic Healthcare Ltd. The test is currently in early-stage development and if this study should be successful, Neurolytic Healthcare will conduct a second larger, independent study in order to apply for CE mark approval that would allow for the selling of the product in the UK. The voucher you receive is a credit that is only applicable after the product has received CE mark approval.

What will happen to the samples I give?

Your saliva sample, and the DNA we extract from it, will be assigned a unique random code and your data will only be identified by this number. The material given to researchers will not have information that identifies you. However, your DNA is unique to you so it can never be completely anonymous. Your saliva and DNA samples will be destroyed after the study period.

What will happen to my data?

We will be using information from you in order to undertake this study. Research is a task that we perform in the public interest. Neurolytic Healthcare Ltd., as sponsor, is the data controller. This means that we, Neurolytic Healthcare Ltd., are responsible for looking after your information and using it properly. We will use the minimum personally-identifiable information possible.

If you wish, we will keep identifiable information about you after the study has finished for as long as it takes to send you a report on our study findings. If you do not wish to receive this follow-up information we will delete any personally identifiable information within 2 months of the end of the research study. We will store any research documents with personal information, such as consent forms, securely at Neurolytic Healthcare Ltd. for 6 months after the end of the study. Finally, any fully anonymised research data generated during this study will be stored indefinitely at Neurolytic Healthcare Ltd. as an integral part of the algorithm.

You can find out more about how we use your information by contacting study@neurolytic-healthcare.com.

What will happen if I don't want to carry on with the study?

You are free to withdraw from the study at any time without giving a reason. This would not affect your legal rights or routine clinical care. If you withdraw from the study, we will immediately destroy the saliva sample that you provided and we can then only make use of the information we already have about you, which will be de-identified.

What happens at the end of the study?

At the end of the study we will produce a study report that summarises the findings of the entire study that will be published on the Neurolytic Healthcare Ltd. website. In this report you will not be personally identifiable, as this data will be displayed in aggregate.

What if we find something unexpected?

As this research study focuses on drug metabolism genes we do not expect to find anything unexpected. Nevertheless, your personalised report provided to you at the end of the study will include details of our findings should you wish to discuss these with your GP.

What if there is a problem?

If you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, you should contact Dr Kumeren Govender (Email: k.govender@neurolytic-healthcare.com).

There are no special compensation arrangements. Neurolytic Healthcare Ltd. will provide indemnity for this study. If you are harmed due to someone’s negligence, then you may have grounds for legal action but you may have to pay for it.

Neurolytic Healthcare Ltd is legally liable for the negligent acts and omissions of its employees. If you are harmed whilst taking part in a clinical trial as a result of negligence on the part of a member of the study team this liability cover would apply.

Non-negligent harm is not covered by our indemnity insurance. Neurolytic Healthcare Ltd., therefore, cannot agree in advance to pay compensation in these circumstances.

How have patients and the public been involved in this study?

Neurolytic Healthcare Ltd. used the Oxford Biomedical Research Centre NIHR Patient and Public Involvement (PPI) programme to publicly reach out to migraine patients in order to receive their input on study design. In particular, when designing this study we have taken into account patient opinions on the frequency of participant visits and the tests that we will carry out.