Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

MiBlock - Botulinum toxin type A blockade of the sphenopalatine ganglion in treatment-refractory chronic migraine

The MiBlock study is investigating a new treatment for people who suffer from chronic migraine, meaning they have frequent headaches that haven't improved with other medicines. The treatment involves injecting a substance similar to Botox near a specific nerve in the face, called the sphenopalatine ganglion. This study is in its final stages of testing (Phase III) to confirm if this treatment is effective. Researchers want to find out if this injection can significantly reduce the number of headache days people experience each month, compared to a placebo (a dummy injection that contains no active medicine). They will also look at whether it reduces how bad the headaches are and if it helps people use less pain relief. This could offer a new option for those struggling with persistent migraine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

St. Olavs Hospital HF

Enrolment target

170

Start

12 Jul 2024

Chronic migraine

What is this study about?

The MiBlock study is looking for new ways to help people who suffer from chronic migraine. Chronic migraine means you get headaches very often, sometimes almost every day, and these headaches can be really debilitating. For many people, existing treatments don't always work well or stop working over time, leaving them in need of other options.

This research is testing a specific type of injection. This injection contains a substance similar to botulinum toxin type A, which you might know as Botox. It will be given near a nerve in your face called the sphenopalatine ganglion. The idea is that blocking this nerve might help reduce the number and severity of migraine headaches. This study is in a late stage of development (Phase III), which means the treatment has already shown some promise in earlier tests, and now researchers want to confirm its effectiveness in a larger group of people.

The main goal of the study is to see if people who receive this injection have fewer headache days each month compared to those who receive a 'dummy' injection (a placebo). The researchers will also carefully monitor any side effects and see if the treatment helps reduce migraine pain, lowers the use of other pain medications, and generally improves people's quality of life.

Key takeaways

This study is for adults with chronic migraine that hasn't responded to other treatments.
It tests an injection of a substance similar to Botox near a facial nerve.
The main goal is to see if the injection reduces the number of headache days.
You might receive the active treatment or a dummy injection (placebo).
Participation involves injections and follow-up visits to monitor your headaches and safety.
The study aims to find a new option for very difficult-to-treat migraines.

Who may be eligible?

To join this study, you generally need to be an adult, aged 18 years or older, with no upper age limit. Both men and women can take part.

The most important thing is that you must have a diagnosis of chronic migraine. This means your migraines are very frequent and have been difficult to treat with standard medications. The study is specifically looking for people whose chronic migraines haven't responded well to other treatments they've tried in the past.

There might be other specific health conditions or medications that would prevent you from joining, as these could affect the study's results or your safety. These details would be discussed thoroughly with you by the study team.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with chronic migraine?
Have other migraine treatments not worked well for you?
Are you willing to potentially receive a placebo (dummy) injection?
Are you comfortable keeping a headache diary during the study?

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 first have a screening visit to make sure you meet all the requirements. If you're eligible, you would then be randomly assigned to either receive the active treatment injection or a placebo injection (which looks the same but contains no active medicine). You wouldn't know which one you're getting, and neither would the doctors, to keep the results fair.

The injections would be given by a healthcare professional. After the treatment, you would have regular follow-up visits over several weeks. During these visits, the study team would check on your progress, ask about your headaches, and look out for any side effects. You would likely be asked to keep a headache diary to record your migraine days and how severe they are. The researchers will compare your headache days between weeks 5 and 8 after the injection to see if there's a difference.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing a new treatment before it's widely available, which might help if your current treatments aren't working. However, there's no guarantee the treatment will work for you, and you might receive the placebo. As with any medical procedure, there are potential risks, such as side effects from the injection itself or the medication. These will be fully explained to you before you agree to take part. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Norway

Common questions

What is chronic migraine?

Chronic migraine means you experience headaches very frequently – typically 15 or more days a month, with at least 8 of those days being migraine headaches, for three months or more.

What is a 'placebo'?

A placebo is a 'dummy' treatment, like an injection that looks the same as the active treatment but contains no medicine. It helps researchers fairly compare the new treatment's effects.

What does a 'Phase III' study mean?

A Phase III study is a late stage of research. It means the treatment has already shown some promise and is now being tested on a larger group of people to confirm its effectiveness and safety before it can be considered for general use.

Will I know if I'm getting the real treatment or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study doctors will know whether you're receiving the active treatment or the placebo. This ensures the study results are as unbiased as possible.

What is 'Botox' and how does it relate to this study?

Botox is a well-known brand name for botulinum toxin type A. This study is using a similar substance, injected near a nerve, to see if it can help reduce migraine headaches.