Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
This study is checking how anti-CGRP medicines (like certain antibodies or gepants) help people with migraine in everyday life over two years. Researchers want to understand if these new treatments make a difference for people with episodic or chronic migraine. They will observe patients who are already prescribed these medicines and meet local health service requirements. The study will look at how effective the treatments are, any side effects people experience, and how the treatments affect their quality of life. This helps us learn more about these important migraine prevention drugs in a real-world setting.
At a glance
What is this study about?
This study is an important look at some newer medicines for migraine. These medicines are called 'anti-CGRP drugs' and they work by targeting a specific substance in the body (CGRP) that plays a key role in migraine attacks. Doctors prescribe these drugs to help prevent migraines rather than just treating a migraine once it starts.
The main goal of this study is to see how these CGRP drugs (like certain antibodies or gepants) work for people in their daily lives, outside of strict clinical trial settings. Researchers want to understand if these treatments genuinely improve things for people who live with migraine, whether they have migraines sometimes (episodic) or very often (chronic).
Over two years, the study will carefully watch people who are already taking these medications. They'll be looking at things like how often migraines occur, how severe they are, any side effects, and how the treatment impacts a person's overall well-being. This kind of 'real-world' study helps doctors and patients understand the true benefits and challenges of these newer migraine prevention medicines.
Key takeaways
- This study looks at how well new migraine prevention drugs (CGRP drugs) work in real life.
- It's for people already prescribed these specific medications for their migraine.
- Participation involves being observed for two years with regular check-ups.
- The study tracks effectiveness, side effects, and impact on daily life.
- It helps us understand these important new migraine treatments better.
Who may be eligible?
To join this study, you would need to have been diagnosed with migraine by a doctor. This diagnosis should follow specific medical guidelines (called ICHD-III).
Crucially, you must also have been prescribed one of the specific anti-CGRP medications that the study is looking at. This prescription needs to meet the criteria set by your doctor and also be covered by your local health service or insurance. You would also need to be willing to sign a consent form, showing you understand and agree to take part.
However, if you have headaches that are definitely not migraine, or if you have a severe mental health condition or memory problems that would make it difficult for you to understand and agree to participate, then this study might not be suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have a medical diagnosis of migraine?
- Am I currently prescribed one of the CGRP anti-migraine medications (like erenumab, galcanezumab, fremanezumab, eptinezumab, atogepant, or rimegepant)?
- Does my prescription meet the criteria set by my doctor and local health service?
- Am I over 18 years old?
- Do I understand what the study involves and feel able to give my consent?
What does participation involve?
If you join this study, you'll be observed for a period of two years. This is an 'observational' study, meaning you'll continue to receive your prescribed CGRP medication as you normally would, based on your doctor's plan and local guidelines. The study itself won't tell you which medication to take or change your treatment plan.
At the beginning, you'll have an initial assessment. After that, you'll have follow-up visits every six months over the two years. During these visits, the study team will check how well the medication is working for you, ask about any side effects you might be experiencing, and discuss how your migraine is affecting your daily life. They'll also ensure you still meet the criteria to continue in the study. The total duration of your involvement in the study will be two years.
Potential risks and benefits
Locations (26)
- University of Miami, Miller School of MedicineVerified postcodeMiami, United States· Recruiting
- FLENIVerified postcodeBuenos Aires, Argentina· Recruiting
- Pontificia Universidad Católica de ChileVerified postcodeSantiago, Chile· Recruiting
- NeuromedicaVerified postcodeMedellín, Colombia· Recruiting
- Special Hospital for Orthopedics and Rehabilitation "Martin Horvat" Rovinj-RovignoVerified postcodeRovinj, Croatia· Recruiting
- Charité Universitätsmedizin BerlinVerified postcodeBerlin, Germany· Recruiting
- LMU University HospitalVerified postcodeMünchen, Germany· Recruiting
- University of L'AquilaVerified postcodeL’Aquila, Italy· Recruiting
- University of Modena and Reggio EmiliaVerified postcodeModena, Italy· Recruiting
- National Neurological Institute C. Mondino FoundationVerified postcodePavia, Italy· Recruiting
- IRCCS San RaffaeleVerified postcodeRoma, Italy· Recruiting
- Universiti Putra MalaysiaVerified postcodeSerdang, Malaysia· Recruiting
Common questions
What kind of medicines are 'CGRP drugs'?
They are newer medicines, either antibodies or gepants, designed to prevent migraines by targeting a specific protein involved in migraine attacks.
Will I get new medicine if I join this study?
No, this study is for people already taking one of these CGRP medicines as prescribed by their doctor.
How long will I be in the study?
Your participation in the study will last for two years.
What does an 'observational study' mean?
It means researchers will observe what happens to you while you take your regular medication; they won't tell you what medicine to take or change your treatment.
Do I have to pay for the study visits?
No, the study visits are part of your participation and you wouldn't be charged for them.
How to find out more
Patricia Pozo-Rosich, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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