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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

MR-Spectroscopy: Investigating neurochemical changes in brain metabolism in migraineurs before and after CGRP-Antibody treatment – a randomized, controlled, open-label trial.

This research is investigating how a treatment for migraine, called Ajovy, affects the brain. Scientists are using advanced MRI scans, called MR-Spectroscopy, to measure specific chemical levels in parts of the brain known to be involved in migraine. They want to see if these brain chemical levels change after 12 weeks of treatment with Ajovy in people who get migraines. The study will compare these changes in people receiving Ajovy with those who aren't, to understand how the medicine works and if these chemical changes are linked to feeling better and having fewer or less severe migraines. It's an important step in understanding how new migraine treatments can help patients.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Medizinische Universitaet Innsbruck
Enrolment target
38
Start
30 Oct 2024

What is this study about?

This study is looking into a medicine called Ajovy, which is already approved for treating migraines. The main goal is to understand exactly how this medicine works inside the brain. Researchers will be using a special type of brain scan, known as MR-Spectroscopy, to check levels of certain chemicals in the brain that are thought to play a role in migraines.

They want to see if these brain chemical levels change after someone has been taking Ajovy for 12 weeks. They will compare these changes with a group of people who are not taking Ajovy, to make sure any differences are due to the medication. This could help us understand why some people get migraines and how treatments like Ajovy might help reduce them.

Besides looking at brain chemicals, the study will also track how often and how badly people get migraines during the treatment period. They'll also compare people who get migraines with aura (visual or other sensory disturbances before a headache) to those who don't. All this information will help doctors understand who might benefit most from this type of treatment and how it improves people's lives.

Key takeaways

  • The study explores how Ajovy affects brain chemistry in people with migraine.
  • It uses special MRI scans to measure brain chemicals.
  • Researchers will compare treated patients with a control group.
  • The study also tracks changes in migraine frequency and severity.
  • Participation involves clinic visits, scans, and questionnaires for about 3 months.
  • It aims to better understand how Ajovy works and who it helps most.

Who may be eligible?

To take part in this study, you must be an adult aged 18 or older. Both men and women are welcome to participate.

Beyond these basic requirements, the research team will check if your specific migraine condition fits the study's needs. This is to make sure the study gathers the most accurate information possible for the questions it's trying to answer.

It's important to discuss your full medical history and current medications with the study doctor to see if you are a good fit for this research.

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.

  1. Are you 18 years old or older?
  2. Do you experience migraines?
  3. Are you willing to have brain scans?
  4. Are you able to attend several clinic appointments?
  5. Are you comfortable with the possibility of receiving a study drug or being in a control group?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several visits to the clinic over a period of time. At the start of the study, you'll have special brain scans (MR-Spectroscopy) to measure your brain chemicals. You'll also fill out questionnaires about your migraines, like how often you get them and how severe they are.

Some participants will receive the Ajovy medicine by injection, which you might learn to do yourself or have done by a nurse. Others will be in a control group, meaning they won't receive the study drug. After 12 weeks of this, you'll have another set of brain scans and fill out the migraine questionnaires again to see if there have been any changes. The total duration of your active participation will likely be around 3 months, including the follow-up assessments.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit by giving you access to new treatments or closer medical monitoring for your migraines. However, there are also potential risks, such as side effects from the medication (like reactions at the injection site, though these are usually mild). The brain scans are generally safe, but some people might feel uncomfortable in the scanner. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Austria

Common questions

What is Ajovy?

Ajovy is a medicine approved to help prevent migraine headaches in adults.

What is MR-Spectroscopy?

It's a special type of MRI scan that measures chemicals in the brain, rather than just showing structures.

Will I definitely get the migraine medicine?

Some participants will receive Ajovy, and others will be in a control group and will not receive the study drug.

How long will the study last for me?

Your active participation, including treatments and assessments, will last for about 12 weeks, plus initial and follow-up visits.

What will happen during the brain scans?

You'll lie still in an MRI scanner, and it will take detailed pictures and chemical measurements of your brain. It's painless but can be noisy.

How to find out more

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

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