Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate efficacy and safety of eptinezumab for the preventive treatment of migraine
This research study is testing a new medicine called VYEPTI. It's for people who experience frequent, severe headaches known as chronic migraine. The study aims to find out if VYEPTI can help prevent these migraines and reduce how often they happen. Researchers will compare VYEPTI to a 'dummy' treatment (placebo) – where some people receive the real medicine and others don't, without anyone knowing who gets what until after the study. This helps them see if VYEPTI genuinely works. The main thing they're measuring is how much the number of migraine days per month changes over 12 weeks for people taking the medicine. They're also looking at how many people have a big reduction in their migraines and whether the medicine is safe to use.
At a glance
What is this study about?
This study is investigating a new medicine called VYEPTI for people who suffer from chronic migraine. Chronic migraine means you experience headaches on 15 or more days a month, with at least 8 of those days being migraine headaches for three months or more. Living with chronic migraine can be very challenging and impact daily life significantly.
The main purpose of this study is to see if VYEPTI can reduce the number of migraine days people experience each month. To do this, some people will receive VYEPTI, while others will receive a placebo – a treatment that looks the same as VYEPTI but doesn't contain any active medicine. Neither you nor your study doctor will know which treatment you are receiving. This is a common and important way to make sure the study results are fair and accurate. Researchers will carefully track how your migraine days change over a period of 12 weeks.
Beyond just counting migraine days, the study will also look at whether VYEPTI can lead to a big improvement in your condition. For example, they'll check if a significant number of people experience 50% or even 75% fewer migraine days. They'll also monitor any side effects to make sure the treatment is safe. This type of study, often called a 'Phase III' study, is a final step to confirm if a new medicine works well and is safe before it can be made widely available.
Key takeaways
- This study is testing a new medicine (VYEPTI) for chronic migraine.
- It aims to see if VYEPTI reduces the number of migraine days.
- The study compares VYEPTI to a placebo (dummy treatment).
- You would receive regular medical care and monitoring.
- Participation involves clinic visits and tracking your symptoms.
- You can leave the study at any time without affecting your care.
Who may be eligible?
To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
The most important requirement is that you must have a diagnosis of chronic migraine. This means you experience a certain number of headache and migraine days each month.
It's important to remember that there will be other specific health requirements and conditions that would mean you could or could not take part. For example, certain other medical conditions or medications might prevent you from joining the study, to ensure your safety and the accuracy of the study results. Your doctor would discuss all these details with you.
- Are you 18 years old or older?
- Have you been diagnosed with chronic migraine?
- Do you get headaches on 15 or more days per month, with at least 8 being migraines?
- Are you able to attend regular clinic visits?
- Are you willing to discuss your full medical history with the study team?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would have an initial screening visit to check if you meet all the requirements. If you're eligible, you would then be assigned to either receive the study medicine (VYEPTI) or a placebo. Neither you nor your study team would know which you're getting.
The VYEPTI or placebo would be given as an infusion, much like an intravenous drip, meaning it's delivered directly into your bloodstream. You would likely need to visit the clinic for these infusions at set times throughout the study period. You would also have regular appointments where study staff would check your health, ask about your migraine symptoms, and monitor any changes.
You would be asked to keep a diary or record of your migraine days and symptoms. The main part of the study involves monitoring your migraines for 12 weeks after the treatment starts, but there would likely be follow-up visits after this main period to continue checking on your health and safety. The total duration of your participation would be fully explained by the study team.
Potential risks and benefits
Locations (3)
- —Poland
- —Slovakia
- —Spain
Common questions
What is chronic migraine?
Chronic migraine means you have headaches on 15 or more days a month, with at least 8 of those days being migraine headaches, for three months or longer.
What is VYEPTI?
VYEPTI is the name of the medicine being tested in this study for preventing migraine headaches.
What is a 'placebo' in a study?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers fairly compare how well the actual medicine works.
Will I know if I'm getting the real medicine?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving VYEPTI or the placebo until after the study is complete.
How long will I be in the study?
The main part of the study measures changes over 12 weeks, but your full participation, including follow-up, could be longer. The study team will give you exact details.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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