AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

The headache- and migraine-inducing effects of apremilast in women with migraine without aura

Migraines are severe, throbbing headaches that can make daily life difficult. People who get migraines without aura do not experience warning signs, such as flashing lights, before their headache begins. Researchers want to better understand the chemical pathways that trigger these attacks. In this study, scientists are testing whether a tablet called apremilast can bring on a migraine attack in women who already have migraine without aura. Apremilast is an approved medicine for skin and joint conditions, but researchers believe it may also act on migraine pathways. Participants will receive either a single dose of apremilast or a dummy pill (placebo). Doctors will monitor participants for 12 hours in a clinic setting. They will check for any headaches, track pain levels, and measure heart rate and blood pressure. The findings could help doctors discover how migraines start and improve future treatments.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Syddansk Universitet (University of Southern Denmark)

Enrolment target

Start

01 Jul 2026

Migraine without aura

What is this study about?

Migraines affect millions of people, yet scientists are still working to understand exactly why and how attacks begin. A migraine without aura is the most common form of migraine. It involves moderate to severe throbbing head pain, often alongside nausea or sensitivity to light and sound, but without warning sensations like blind spots or tingling beforehand.

This trial investigates a medicine named apremilast. Apremilast is already used safely to treat other conditions, such as psoriasis and arthritis, because of how it dampens certain inflammatory signals. However, researchers have found that activating these same pathways might actually trigger a migraine in people prone to them. By deliberately testing this effect under safe, controlled medical supervision, scientists hope to pinpoint the exact signals that spark migraine attacks.

During the trial, women with migraine without aura will receive either one 30 mg tablet of apremilast or an inactive dummy tablet (placebo). Neither the participants nor the immediate research team will know who receives which tablet until the end. Researchers will closely observe participants for 12 hours, checking their heart rate, blood pressure, and any headache symptoms that arise.

Understanding what triggers migraines at a biological level is a crucial step in modern medicine. If researchers can prove which cellular pathways spark attacks, pharmaceutical companies and doctors can design more targeted, effective medicines to stop migraines before they even start.

Key takeaways

The trial tests whether a single dose of apremilast can trigger migraine attacks in women.
Participants will receive either apremilast or a dummy tablet (placebo).
Doctors will monitor your headache symptoms, heart rate, and blood pressure for 12 hours in a clinic.
You must be a woman aged 18 or older with a history of migraine without aura.
Taking part helps scientists understand what sparks migraines so they can develop better treatments.

Who may be eligible?

This trial is designed for adult women aged 18 and older who have a confirmed medical history of migraine without aura. Migraine without aura means your headaches happen without early warning signs like flashing lights, zigzag lines, or numbness.

Because the study is looking specifically at biological responses in women, only female participants are able to take part.

People with certain medical conditions, serious heart issues, or known allergies to the study ingredients (including lactose) may not be suitable. The clinical trial team will go through a full health check with you to decide if taking part is safe for your individual circumstances.

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.

I am a woman aged 18 or over.
I have been diagnosed with migraines.
My migraines happen without aura (no visual flashes or tingling warnings beforehand).
I am able to attend a clinic for a 12-hour continuous monitoring period.
I do not have a known allergy to lactose monohydrate.

Answer every question to see your result.

What does participation involve?

Taking part involves visiting a clinical research centre for an observation day. During the visit, you will take a single tablet by mouth—either 30 mg of apremilast or a dummy tablet (placebo) made of lactose. You will stay at the clinic for at least 12 hours so the doctors can watch you closely. During this time, the study team will regularly check your blood pressure and heart rate (especially during the first 90 minutes) and ask you about any headache symptoms, tracking how severe they are. If you develop a migraine attack, the medical team will provide care and record how long it lasts. Once the 12-hour period is complete and you are feeling well, you will be able to go home, with follow-up contact arranged to ensure you have fully recovered.

Potential risks and benefits

You will not gain any direct personal medical benefit from taking part, but your involvement will help researchers better understand what causes migraine pain, which could benefit others in the future. The primary risk is that the study medicine may trigger a temporary migraine or headache. You might also experience mild side effects from apremilast, such as an upset stomach or temporary changes in your pulse and blood pressure. Doctors will be on hand the entire time to manage any symptoms and keep you comfortable. Taking part is completely your choice, and you can withdraw from the study at any point without it affecting your normal 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 a placebo?

A placebo is a harmless dummy tablet that looks identical to the real medicine but contains no active drug. In this trial, it contains lactose. It allows researchers to see if effects are genuinely caused by the medicine.

Will taking this medicine definitely give me a migraine?

Not necessarily. The study aims to see if apremilast causes migraines more often than the dummy pill, but it may not trigger an attack in every person who takes it.

What happens if I get a very painful headache during the trial?

The research team will be with you throughout the 12-hour observation period. They will closely record your pain and provide appropriate medical treatment to relieve your symptoms when safe to do so.

Can I leave the study early if I feel uncomfortable?

Yes. Participation is voluntary. You have the right to withdraw at any time, for any reason, and your regular NHS healthcare will not be affected.

Do I have to pay to take part?

No. Clinical trials in the UK do not charge participants. In many cases, travel expenses to and from the clinic are reimbursed.