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?
- 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?
We hope that this could improve the lives of millions around the world who suffer from migraine.
Do I have to take part?
What will happen to me if I decide to take part?
- 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?
Are there any possible disadvantages or risks from taking part?
What are the possible benefits of taking part?
Will my General Practitioner/family doctor (GP) be informed of my participation?
Will my taking part in the study be kept confidential?
Will I be reimbursed for taking part?
What will happen to the samples I give?
What will happen to my data?
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 firstname.lastname@example.org.
What will happen if I don't want to carry on with the study?
What happens at the end of the study?
What if we find something unexpected?
What if there is a problem?
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.