A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine
This study is looking into a new treatment called Xeomin for people who get episodic migraines. Participants will receive injections of either Xeomin or a dummy injection (placebo) into the muscles of their head and neck. The main goal is to see if Xeomin can significantly lower the number of migraine days each month. We'll also be checking if the treatment is safe. This is a Phase 3 study, meaning it's one of the final stages before a treatment might become more widely available. It's important for patients to understand that some will receive the active treatment and some won't, to allow for fair comparison.
At a glance
What is this study about?
This study is designed to explore a new treatment called Xeomin for people who suffer from episodic migraines. Episodic migraines are a type of migraine where you experience headaches on some days, but not constantly. The researchers want to find out if Xeomin injections can make a real difference in how many migraine days someone has each month, and whether it's a safe treatment option.
To do this, some participants will receive the Xeomin injection, while others will receive a 'placebo' injection. A placebo looks just like the real treatment but doesn't contain any active medicine. This allows the researchers to fairly compare how well Xeomin works against not receiving the active drug. Neither the participants nor the doctors will know who is getting which injection during the study.
By carefully tracking migraine days and any side effects over a long period, the researchers hope to understand if Xeomin could be a useful new way to help people manage their episodic migraines.
Key takeaways
- This study is testing Xeomin injections for episodic migraines.
- It aims to reduce monthly migraine days and check safety.
- Some participants will get Xeomin, others a dummy injection (placebo).
- The study lasts about a year with regular visits, some in-person, some remote.
- Eligibility depends on your migraine history and other medications.
Who may be eligible?
To join this study, you need to have been diagnosed with episodic migraine for at least a year and be able to tell the difference between a migraine and other headaches. Your migraines should have started before you were 50 years old. In the three months before the study starts, you should have had no more than 14 headache days in total each month, and specifically between 6 and 14 migraine days per month. These numbers will also be checked during the last month of the initial screening period.
There are also some reasons why you wouldn't be able to join. For example, if you have chronic migraine (migraines very frequently), or other specific types of headache like 'migraine with brainstem aura' or 'hemiplegic migraine', you wouldn't be eligible. Also, if you're currently taking more than one medication specifically to prevent migraines, or if you recently stopped a particular type of migraine prevention treatment (CGRP inhibitors) within the last five months, you wouldn't be able to participate. Having a headache due to overusing medication is usually okay, as is having tension headaches.
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.
- I have been diagnosed with episodic migraines for at least one year.
- My migraines started before I turned 50.
- In the last 3 months, I had between 6 and 14 migraine days per month.
- I am not currently taking more than one regular medication to prevent migraines.
- I haven't recently stopped specific anti-CGRP migraine prevention treatments in the last 5 months.
What does participation involve?
If you decide to take part, the study will last between 52 and 55 weeks, which is about a year. It starts with a screening period of about 4 to 5 weeks to make sure you meet all the requirements.
During the main part of the study, you'll receive injections four times, with each set of injections about 12 weeks apart. You'll have a total of 14 visits throughout the year. The first visit, the last visit, and the four visits where you get injections will be in person at the clinic. The other eight visits will be done remotely, meaning you can speak to the study team over the phone or by video call, usually every four weeks.
Potential risks and benefits
Locations (108)
- TrialSphere Corp, Merz Investigational Site #0010513Verified postcodeChandler, United States· Recruiting
- Arizona Neuroscience Research, Merz Investigational Site #0010521Verified postcodePhoenix, United States· Recruiting
- Baptist Health Medical Center, Merz Investigational Site #0010520Verified postcodeLittle Rock, United States· Recruiting
- Chemidox Clinical Trials Inc, Merz Investigational Site #0010488Verified postcodeLancaster, United States· Recruiting
- Clinical Research Institute, Merz Investigational Site #0010487Verified postcodeLos Angeles, United States· Recruiting
- Clinical Trials Management Services, Merz Investigational Site #0010526Verified postcodeThousand Oaks, United States· Recruiting
- BNL Health Inc., Merz Investigational Site #0010489Verified postcodeTorrance, United States· Recruiting
- Hasbani Neurology, Merz Investigational Site #0010509Verified postcodeNew Haven, United States· Recruiting
- Yale Center for Clinical Investigations, Merz Investigational Site #0010527Verified postcodeNew Haven, United States· Recruiting
- New England Institute Neurology and Headache, Merz Investigational Site #0010441Verified postcodeStamford, United States· Recruiting
- Northwest Florida Clinical Research Group, Merz Investigational Site #0010286Verified postcodeGulf Breeze, United States· Recruiting
- Nexus Clinical Research Center, Merz Investigational Site #0010514Verified postcodeHomestead, United States· Recruiting
Common questions
What is Xeomin?
Xeomin is a type of injection being tested to see if it can help reduce the number of migraine days for people with episodic migraines.
What is a 'placebo'?
A placebo is a dummy injection or treatment that looks exactly like the real thing but contains no active medicine. It helps researchers compare the real treatment fairly.
How often will I get injections?
If you are in the treatment group, you will receive injections four times, with each set of injections about 12 weeks apart.
How long will the study last?
The entire study will last for about a year, specifically between 52 and 55 weeks.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, without losing access to your regular medical care.
How to find out more
Public Disclosure Manager
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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