AuthorisedTherapeutic confirmatory (Phase III)Interventional

Prevention of chronic headache with anti-CGRP antibody treatment in patients with idiopathic intracranial hypertension

If you have a condition called idiopathic intracranial hypertension (IIH) and suffer from long-lasting headaches, this study might be for you. Researchers are testing a new medication, called an anti-CGRP antibody, to see if it can prevent chronic headaches in people with IIH. Idiopathic intracranial hypertension is a condition where there's too much pressure fluid around the brain, which can cause headaches. The new medicine aims to block a protein known to be involved in headache pain. This is a Phase 3 study, meaning it's a large, important trial to confirm if the treatment is safe and effective before it can potentially be made widely available. It's hoped this research will lead to better ways to manage the headaches associated with IIH.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Rigshospitalet

Enrolment target

Start

13 Apr 2026

Idiopathic intracranial hypertension

What is this study about?

This study is investigating a new way to prevent chronic headaches in people who have a condition called idiopathic intracranial hypertension (IIH). IIH is when there's a build-up of pressure from the fluid surrounding your brain, even though there's no obvious reason for it. This extra pressure can often lead to very frequent and severe headaches.

The new treatment being tested is a type of medicine called an anti-CGRP antibody. To put it simply, CGRP is a natural protein in your body that plays a role in causing headache pain. This new medicine is designed to block or reduce the activity of CGRP, with the goal of preventing those headaches from starting or making them less severe.

This is a clinical trial, which means researchers are carefully studying the new medicine to see if it works well and is safe for people with IIH who experience chronic headaches. It's a 'Phase 3' study, which is the final stage of testing before a new medicine can be considered for approval. Finding better ways to manage these headaches could significantly improve the quality of life for people living with IIH.

Key takeaways

This study is for adult women with Idiopathic Intracranial Hypertension (IIH) and chronic headaches.
It's testing a new medicine (anti-CGRP antibody) to prevent these headaches.
It's a Phase 3 study, meaning it's a large trial to confirm effectiveness and safety.
Participation involves regular clinic visits, assessments, and receiving study medication.
There are potential benefits like headache relief, but also potential risks and side effects.
You can withdraw from the study at any time.

Who may be eligible?

This study is specifically looking for adult women who have been diagnosed with idiopathic intracranial hypertension (IIH) and regularly experience chronic headaches. You'll need to be at least 18 years old to take part.

There might be some other health conditions or medications that would prevent you from joining the study, as researchers need to make sure the treatment is safe for everyone involved and that results are clear. For example, if you have other serious medical problems, or are already taking certain headache prevention medicines, you might not be suitable.

It's important to remember that not everyone who has IIH and headaches will be a good fit for this particular study. The research team will carefully check all your medical information to see if you meet all the necessary requirements.

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 an adult woman (18 years or older)?
Have you been diagnosed with Idiopathic Intracranial Hypertension (IIH)?
Do you experience chronic (long-lasting/frequent) headaches?
Are you able to attend regular study appointments?
Are you willing to potentially receive a new, unapproved medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have regular visits to a clinic or hospital for assessments. These visits might involve physical examinations, discussions about your headaches, and possibly blood tests or other scans to monitor your health and the effects of the treatment. You would receive the study medication, which might be given as an injection or infusion, depending on the specific drug.

Over the course of the study, you would be asked to keep track of your headaches, perhaps in a diary. Researchers would periodically check in with you to see how you are feeling and if your headaches have changed. The total duration of your participation in the study would be explained to you in detail by the research team, but studies of this type often last for several months or even longer, with follow-up appointments after the main treatment period.

Potential risks and benefits

Taking part in a study like this could potentially offer new ways to manage your chronic headaches, which might be a significant benefit if current treatments aren't working well for you. However, as with any new medicine, there are potential risks, such as side effects, which the research team will explain fully. These side effects can range from mild (like pain at the injection site) to more serious, though rare, reactions. You will be closely monitored throughout the study for any health changes. It's a good idea to discuss all potential risks and benefits with your doctor before deciding, and remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Denmark

Common questions

What is idiopathic intracranial hypertension (IIH)?

IIH is a condition where the pressure of the fluid around your brain is higher than normal. The 'idiopathic' part means there isn't a clear reason why the pressure is high.

What is an anti-CGRP antibody?

It's a type of medicine that targets a protein in your body called CGRP, which is involved in causing headache pain. By blocking it, the medicine aims to prevent headaches.

What does 'Phase 3' mean for a study?

Phase 3 means it's a large study, usually involving many people, to confirm if a new medicine is effective and safe compared to existing treatments or a placebo, before it can be considered for wider use.

Will I get the actual medicine or a dummy treatment?

In many Phase 3 studies, some participants receive the new medicine, and others receive a 'dummy' treatment (placebo) or a standard treatment. This helps researchers fairly compare how well the new medicine works.

Does taking part cost me anything?

Usually, clinical trials cover the costs of study-related medical care, tests, and the medication. This will be made clear to you before you agree to join.