AuthorisedTherapeutic exploratory (Phase II)Interventional

OmaMig Pilot: An open-label, phase IIa, single arm pilot study evaluating the potential clinical benefit and safety of omalizumab in adults with episodic migraine.

This study is looking into a medicine called omalizumab, also known as Xolair, for people who experience episodic migraines. These are migraines that happen regularly but not every day. The main aim is to find out if this medicine can lower the number of migraine days a person experiences over about three months. We're also checking how safe the medicine is by watching out for any side effects. This is a small, early-stage study, so it's a first step to understand if Xolair could be a good treatment option for episodic migraine in the future. Participants will receive the medicine and be monitored closely.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Oslo University Hospital HF

Enrolment target

Start

31 Mar 2026

Episodic migraine

What is this study about?

This study is investigating a medicine called omalizumab, which you might know by its brand name, Xolair. It's being tested for adults who have 'episodic migraines'. This means you get migraines regularly, but not so often that they become chronic (almost daily). The main purpose of this study is to see if Xolair can help reduce how often people get these migraines. We will be looking at whether it lowers the number of days you experience a migraine over a period of about three months after starting the treatment.

This is an early-stage study, referred to as 'Phase II'. This means it's a pilot study, a bit like a trial run, to see how well the medicine works and if it's safe for this specific condition. We're giving the medicine to people and carefully monitoring them to understand its effects. This helps researchers decide if it's worth doing larger studies in the future.

Besides tracking migraine days, we'll also be keeping a close eye on any side effects, how strong and long-lasting your migraines are, and if other rescue medicines still help. We'll also check how much of the medicine you need and how many people see a big drop in their migraine frequency. This detailed information helps us get a full picture of how Xolair might help people with episodic migraines.

Key takeaways

This study tests Xolair (omalizumab) for episodic migraines.
It aims to see if Xolair reduces the number of migraine days.
It also checks the medicine's safety and any side effects.
It's a pilot (early-stage) study for adults aged 18 and over.
Participation involves injections and regular health checks.
You can leave the study at any time without affecting your care.

Who may be eligible?

This study is looking for adult volunteers, meaning you must be at least 18 years old. There is no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part in this research.

To be eligible, you need to have a diagnosis of 'episodic migraine'. This generally means you experience migraines regularly but not every day. The researchers will check your medical history to make sure you fit the specific criteria for this type of migraine.

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 episodic migraines (not chronic)?
Are you willing to receive injections?
Are you able to attend regular study visits over several months?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the study medicine, Xolair, which is given as an injection. Throughout the study, you'll have regular visits where doctors and nurses will monitor your health and how the medicine is affecting your migraines. They will ask you about the number of migraine days you have, the severity of your migraines, and any other medications you take.

The initial part of the study will involve a monitoring period of about 4 weeks before you start the medicine. After that, you'll receive the medicine and be monitored for about 12 to 16 weeks. During this time, they’ll check for any side effects and see how your migraines change. The total duration of your participation in the study is approximately 4-5 months, including the initial screening and follow-up.

Potential risks and benefits

Taking part in this study could potentially offer you a new way to manage your episodic migraines, and you'll receive close medical attention. However, as with any medicine, there's a chance of side effects, some of which could be serious. The research team will explain all known risks to you. Remember, joining a study is always your choice, and you have the right to leave 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.

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Unverified
Norway

Common questions

What is omalizumab (Xolair)?

Omalizumab, sold as Xolair, is a medicine that works by blocking a substance in your body often linked to allergic reactions and inflammation. This study is exploring if it can help with migraines.

What is an episodic migraine?

Episodic migraine means you get migraines regularly, but they don't happen every day or almost every day. It's different from chronic migraine.

How will I know if the medicine is working?

The study will track the number of migraine days you have, how bad they are, and if your other medicines still help. These will be compared before and after starting Xolair.

How is the medicine given?

Xolair is given as an injection, typically with a pre-filled syringe. The study team will show you or give you the injection.

Can I stop taking part in the study if I want to?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your current or future medical care.