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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medication phase
The administration of omalizumab begins. this is a 300 mg solution delivered via subcutaneous injection, which means the medicine is injected into the fatty tissue just under the skin.
Step 2
Monitoring period
The progress of the episodic migraine condition is tracked through week 8 to week 12 to observe changes in the number of migraine days.
Monitoring continues until week 16 to identify any adverse events, which are any side effects or unexpected medical occurrences.

Who can join the trial?

5 criteria

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 trial?

4 criteria

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.

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Verified sites

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Oslo Universitetssykehus HF
Oslo, Norway

Trial locations

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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.

Omalizumab

What is already known about the treatment

Omalizumab - This medication is given as a shot injected just under the skin using a pre-filled syringe. While it is already approved for other uses, it is being studied here for its potential to help adults suffering from episodic migraines. It works by attaching itself to a specific protein in the body called IgE, which helps block the allergic and inflammatory responses that can trigger headaches. This drug belongs to a class of medicines known as monoclonal antibodies.

Investigated diseases

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.