Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Interventional, randomized, double-blind, parallel-group, placebo-controlled, dose-finding trial of Lu AG09222 for the prevention of migraine in participants with episodic and chronic migraine. Lundbeck trial no: 20297A

This research study is looking at a new investigational medicine called Lu AG09222. The main goal is to find out if this medicine can help prevent migraines in adults who experience them regularly. This includes people with both episodic migraine (where headaches happen sometimes) and chronic migraine (where headaches are very frequent). We also want to find the right amount, or dose, of the medicine that works best and is safe. Some participants will receive the investigational medicine, while others will receive an inactive substance (placebo) for comparison. The study will track how many migraine days people have and check for any side effects. This is an important step in finding new ways to manage migraine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

H. Lundbeck A/S

Enrolment target

552

Start

22 Jul 2024

Migraine

What is this study about?

This study is about exploring a new medicine, Lu AG09222, to see if it can help stop migraines before they even start. For many people, migraines can be a huge struggle, making everyday life very difficult. This study hopes to find an effective new treatment that could reduce the number of migraine attacks and make them less severe. It's a 'dose-finding' study, which means researchers are also trying to figure out the best amount of the medicine for patients.

The researchers will compare the new medicine against a 'placebo', which looks exactly like the medicine but contains no active ingredients. This helps them understand whether any improvements are truly due to the medicine or something else. Participants won't know if they're getting the medicine or the placebo, and neither will their study doctor – this is called 'double-blind' and it helps make the results fair and accurate.

Ultimately, this study aims to gather important information about how well Lu AG09222 works to prevent migraines and what side effects it might have. This kind of research is crucial for developing new and better treatments for migraine sufferers in the future.

Key takeaways

This study is testing a new medicine (Lu AG09222) to prevent migraines.
It's for adults with either episodic or chronic migraine.
Some participants will receive the active medicine, others a placebo.
The study aims to find the most effective and safest dose.
Participants will keep a migraine diary and have regular health checks.
Your decision to join is voluntary, and you can leave at any time.

Who may be eligible?

This study is looking for adult volunteers aged 18 and over. There is no upper age limit, meaning older adults are also welcome to participate.

Both men and women can take part in this research. The study needs a diverse group of participants to get a good understanding of how the new medicine might work across different people.

To be considered for this study, you must have been diagnosed with either episodic migraine (meaning you get migraines sometimes) or chronic migraine (meaning you get migraines very frequently). The study team will check other specific health details to make sure this study is safe and suitable for you.

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 migraines (either sometimes or very often)?
Are you able to attend regular clinic visits?
Are you willing to keep a diary of your migraines?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be asked to take a study medicine or a matching placebo. You won't know which one you're getting, and neither will your study doctor. You'll keep a diary of your migraines, likely for 12 weeks, noting down when they happen and how severe they are. You will also have regular visits to the clinic where the study team will take blood tests, check your blood pressure, weight, and heart (with an ECG). They will also ask you about any side effects you might be experiencing and how you are feeling generally. The total duration of your participation in the study, including follow-up after you stop taking the medicine, will be explained by the study team.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. You might benefit from a new medicine that could help prevent your migraines, but there's also a chance you could receive a placebo and your migraines may not improve. Like all medicines, this investigational drug may have side effects, which the study team will monitor closely. You will be told about all the known risks before you decide to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

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

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Unverified
Hungary
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Unverified
Lithuania
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Unverified
Slovakia
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Unverified
Romania
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Unverified
Czechia
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Unverified
Poland
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Unverified
Denmark
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Unverified
Germany
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Unverified
Bulgaria
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Unverified
France
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Unverified
Spain

Common questions

What specifically is a 'placebo'?

A placebo looks exactly like the study medicine but contains no active drug. It helps researchers see if the real medicine is actually working, or if improvements happen for other reasons.

Will I know if I'm getting the actual medicine or the placebo?

No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps keep the study fair and the results accurate.

How long will I be involved in the study?

The main part of the study where you're taking the medicine and tracking migraines is for 12 weeks, but your full involvement, including initial screening and follow-up, will be longer. The study team will tell you the exact time commitment.

What kind of information will I need to record?

You will be asked to keep a detailed diary, specifically noting your migraine days each month. This helps track how well the medicine is working.

What is the purpose of drawing blood and doing ECGs?

These tests are important for your safety. They help the study team monitor your overall health, check for any changes caused by the study medicine, and make sure it's safe for you to continue participating.