RecruitingPHASE3INTERVENTIONAL

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

This clinical trial is looking at how well and how safely a medication called Xeomin works to prevent very frequent (chronic) migraines. People taking part will get injections in their head and neck muscles, either Xeomin or a dummy injection (placebo). The main goal is to find out if Xeomin injections can lower the number of days people experience migraines each month. The study will last around a year, with a few visits to the clinic for treatments and check-ups, and some remote check-ins. If you have chronic migraines, this study aims to explore a potential new way to manage them.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merz Therapeutics GmbH

Enrolment target

780

Start

21 Aug 2025

Estimated completion

01 Mar 2028

Chronic Migraine

What is this study about?

This study is a clinical trial exploring a new treatment option for people who experience chronic migraine. Chronic migraine means you have headaches very often – typically 15 or more days a month, with 8 or more of those being migraine days. It can be incredibly disruptive to daily life, and finding effective ways to manage it is really important.

The treatment being tested is called Xeomin. It's given as injections into the muscles of the head and neck. We want to see if these injections can help reduce how often people get migraines. To do this fairly, some participants will receive the actual Xeomin injections, while others will receive a 'placebo' – which looks exactly like Xeomin but doesn't contain any active medicine. This allows researchers to compare the effects of Xeomin against what would happen if people weren't getting the active drug.

The main aim of the study is to measure if people receiving Xeomin have fewer migraine days each month compared to those receiving the placebo. This kind of research is vital because it helps doctors and patients understand if a new treatment is safe and effective before it becomes widely available. We're hoping to find a new way to bring relief to those suffering from chronic migraine.

Key takeaways

Tests a new injection (Xeomin) for chronic migraine.
Compares Xeomin to a dummy injection (placebo).
Involves injections in head and neck muscles.
Study lasts about one year with in-person and remote visits.
Aims to reduce the number of migraine days.
Suitable for adults with long-term frequent migraines.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and have been diagnosed with chronic migraine for at least a year. Your migraines should have started before you turned 50. For the three months before the study starts, and during the final month of screening, you should have had at least 15 headache days per month, with at least 8 of those being migraine days.

There are also some reasons why you might not be able to join. For example, if you have other specific types of headache diagnoses (apart from common tension headaches or medication overuse headaches), or if you're currently taking more than one medication specifically to prevent migraines. Also, if you've recently stopped a certain type of migraine prevention medication (called anti-CGRP/anti-CGRP receptor treatment) within the last five months, you wouldn't be eligible.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with chronic migraine for at least a year?
Did your migraines start before you turned 50?
Do you currently have headaches on at least 15 days a month, with at least 8 of those being migraines?
Are you *not* currently taking more than one prescribed medication specifically to prevent migraines?
Have you *not* stopped CGRP migraine prevention treatment within the last 5 months?

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, the study will last about 52 to 55 weeks, which is roughly one year. It starts with a ‘screening’ period of 4 to 5 weeks to make sure the study is a good fit for you.

During the study, you'll receive four sets of injections. Each set of injections will be given about 12 weeks (3 months) apart. You'll have 14 visits in total over the year. The first and last visits, along with the four treatment visits where you get your injections, will be in person at the study clinic. The other 8 check-ups will be done remotely, meaning you can do them from home over the phone or by video call. You'll also be asked to keep a headache diary to track your migraines.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't yet widely available, and you'll be closely monitored by medical professionals. However, there's no guarantee the treatment will work for you, and there might be side effects from the injections or other aspects of the study. The injections involve needles, which can cause discomfort or bruising. You might also experience side effects like muscle weakness or headaches, though we don't know the full range yet for Xeomin in this setting. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (108)

TrialSphere Corp, Merz Investigational Site #0010513
Chandler, United States· Recruiting
Arizona Neuroscience Research, Merz Investigational Site #0010521
Phoenix, United States· Recruiting
Baptist Health Medical Center, Merz Investigational Site #0010520
Little Rock, United States· Recruiting
Chemidox Clinical Trials Inc, Merz Investigational Site #0010488
Lancaster, United States· Recruiting
Clinical Research Institute, Merz Investigational Site #0010487
Los Angeles, United States· Recruiting
BNL Health, Merz Investigational Site #0010501
Los Angeles, United States· Recruiting
Clinical Trials Management Services, Merz Investigational Site #0010526
Thousand Oaks, United States· Recruiting
Hasbani Neurology, Merz Investigational Site #0010509
New Haven, United States· Recruiting
Yale Center for Clinical Investigations, Merz Investigational Site #0010527
New Haven, United States· Recruiting
New England Institute Neurology and Headache, Merz Investigational Site #0010441
Stamford, United States· Recruiting
Northwest Florida Clinical Research Group, Merz Investigational Site #0010286
Gulf Breeze, United States· Recruiting
Nexus Clinical Research Center, Merz Investigational Site #0010514
Homestead, United States· Recruiting

+96 more sites — see the official record for the full list.

Common questions

What is chronic migraine?

Chronic migraine means you experience headaches on 15 or more days per month, with at least 8 of those days being migraines, over a period of three months or more.

What is 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active drug. It helps researchers fairly compare the new treatment's effects.

Will I know if I'm getting Xeomin or the placebo?

No, during the study, neither you nor the study team will know whether you are receiving Xeomin or the placebo. This helps keep the study fair.

How long does each treatment last?

You will receive four treatments in total, with each set of injections given approximately 12 weeks (3 months) apart.

Can I stop participating in the study if I change my mind?

Yes, you are free to stop participating in the study at any time, for any reason, without it affecting your future medical care.

How to find out more

Public Disclosure Manager

clinicaltrials@merz.com +49691503 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.