Interventional, randomized, double-blind, parallel-group, placebo-controlled study of add-on eptinezumab treatment to brief education intervention, for the preventive treatment of migraine in patients with a dual diagnosis of migraine and Medication Overuse Headache.
This study is testing a new way to help people who suffer from regular migraines and also use a lot of pain relief for their headaches. This condition is sometimes called Medication Overuse Headache. The study involves a medicine called VYEPTI. Half the people in the study will receive VYEPTI, while the other half will receive a dummy treatment (a placebo), but neither the participants nor the doctors will know who is getting which. Everyone in the study will also receive some simple education about managing their headaches. The main goal is to see if VYEPTI helps reduce the number of headache days each month and generally improves headache management over several weeks. It's a way to accurately check if VYEPTI is effective for this specific group of patients.
At a glance
What is this study about?
This research study is for people who experience frequent migraines, also known as chronic migraine, and who also regularly use pain medication to treat their headaches. Sometimes, using too much pain relief can actually make headaches worse or more frequent, which doctors call Medication Overuse Headache.
The study aims to find out if a medicine called VYEPTI can help reduce the number of headache days for these individuals. Participants will receive either VYEPTI or a 'dummy' treatment (a placebo), along with some basic advice on understanding and managing their headaches. Neither the participants nor their doctors will know who is getting VYEPTI and who is getting the placebo until the study is over. This is a common and important way to fairly test if a new treatment works.
Researchers will be carefully tracking several things, especially how many days you have a headache each month. They will also look at how often you use your acute pain medication and how your daily pain levels change. This approach helps the research team understand if VYEPTI, when added to general headache advice, can make a real difference for people with both chronic migraine and medication overuse headache.
Key takeaways
- This study is for adults with frequent migraines and medication overuse headaches.
- It tests a drug called VYEPTI against a dummy treatment.
- Everyone gets headache education and close medical monitoring.
- The main goal is to reduce headache days and acute pain medication use.
- Participation involves clinic visits and tracking your headaches for about 12 weeks.
Who may be eligible?
This study is looking for adults who are at least 18 years old. Both men and women can take part.
To be eligible, you must have a formal diagnosis of chronic migraine, meaning you get headaches very often, and also have Medication Overuse Headache. This means you regularly use pain relief for your headaches, and this might be making your headaches worse.
There might be other health conditions or medications that would prevent you from taking part, but the study team will discuss all of these details with you if you are interested.
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.
- Are you 18 years old or older?
- Do you get very frequent migraines (most days of the month)?
- Have you been told you have 'Medication Overuse Headache' because you use pain relief regularly?
- Are you able to attend clinic appointments and keep a headache diary?
What does participation involve?
If you join this study, it will involve several visits to the clinic over a period of about three months (12 weeks). At these visits, you will receive either the study medication (VYEPTI) or the placebo as an infusion, which means it will be given through a drip into your arm. You will also get some simple information about managing your headaches.
The study team will ask you to keep a headache diary or complete questionnaires to track your headache days, how much pain medication you use, and your general headache experience. They will perform regular health checks and assessments to see how you are doing, including blood tests if necessary. You will have regular contact with the study team to support you throughout your participation. At any point, you are free to stop participating in the study without giving a reason.
Potential risks and benefits
Locations (8)
- —UnverifiedNetherlands
- —UnverifiedNorway
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedDenmark
- —UnverifiedSweden
- —UnverifiedFrance
Common questions
What is chronic migraine?
Chronic migraine means you experience headaches very often, typically 15 or more days a month, with at least 8 of those days being migraines, for three months or more.
What is Medication Overuse Headache?
This happens when you take pain relief medication too often for headaches, and this actually causes your headaches to become more frequent or severe.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers fairly test if the actual medicine works better than doing nothing or having the psychological effect of receiving a treatment.
What is VYEPTI?
VYEPTI is a medicine designed to prevent migraines by blocking a specific protein in the body that is involved in migraine attacks.
How long will I be in the study?
Your participation will last for about 12 weeks, which is roughly three months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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