A study to evaluate the safety and effectiveness of omalizumab in adults with episodic migraine

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What is this study about?

This study focuses on individuals living with episodic migraine, a condition characterized by recurring headaches that occur at certain intervals. The purpose of the study is to evaluate the potential benefit and safety of a medication called omalizumab, which is also known by the brand name Xolair. This medicine is administered as a subcutaneous injection, which means it is delivered through a needle into the fatty layer of tissue just under the skin.

Participants will receive the medication to see how it affects the number of days they experience a migraine each month. During the study, the frequency, intensity, and duration of the headaches will be monitored. The researchers will also observe any adverse events, which are any side effects or unexpected health changes that occur during the treatment period.

Who Can Join the Study?

  • You must be an adult, which typically means you are aged 18 years or older.
  • You must have episodic migraine, which is a type of headache disorder where migraine attacks happen at certain times rather than being constant.
  • You must experience between 4 and 14 migraine days in a single month.
  • Your migraines may or may not include an aura, which refers to temporary visual disturbances or other sensory changes that happen just before a headache starts.
  • Your headache patterns must meet the specific standards set by the International Classification of Headache Disorders (ICHD-3), which is the official global system used by doctors to identify and name different types of headaches.

Who Cannot Join the Study?

  • Using any other migraine preventive medications, which are medicines taken regularly to reduce how often a headache occurs, while taking part in this study.
  • Having interval headaches, which are headaches that happen between migraine attacks, that cannot be clearly told apart from a migraine.
  • Having tried three or more prophylactic drugs, which are preventative medicines used to stop headaches from starting, for migraine in the last 10 years.
  • Being pregnant or breastfeeding.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Not yet recruiting
01.01.2026

Trial locations

Investigated drugs:

Xolair is an injectable medication used to see if it can help reduce the number of days a person experiences migraines each month.

Episodic migraine – This condition involves recurring bouts of intense headaches that occur at irregular intervals. These episodes are often characterized by throbbing pain, typically on one side of the head. During an attack, individuals may also experience sensitivity to light and sound, or nausea. The attacks vary in frequency and can last from a few hours to several days. The pattern is defined by periods of being symptom-free interrupted by these specific headache events.

Trial ID:
2025-522448-41-00
Protocol code:
OmaMig Pilot
Trial Phase:
Therapeutic exploratory (Phase II)

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