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RecruitingPhase I and Phase II (Integrated)- OtherInterventional

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

Migraine is a painful condition, but scientists still need to learn more about how attacks start. In this study, researchers are using a medication called cilostazol, which is known to trigger temporary migraine-like headaches in people who are prone to them. The trial aims to see if men and women react differently to the drug, and how it compares to a dummy tablet (placebo). Participants will take a tablet and be observed in a clinic for up to 12 hours. Doctors will check their blood pressure, heart rate, and any headache symptoms. Taking part will not cure your migraines, as the goal is to safely trigger and study an attack in a controlled setting. If you do get a headache, standard pain-relief treatments like ibuprofen or sumatriptan will be provided right away to help you feel comfortable again.

At a glance

Status
Recruiting
Phase
Phase I and Phase II (Integrated)- Other
Sponsor
Syddansk Universitet (University of Southern Denmark)
Enrolment target
29
Start
20 Jun 2025

What is this study about?

Migraines are severe headaches that often come with sickness and sensitivity to light or sound. While they are very common, doctors do not fully understand all the chemical pathways in the body that start an attack. In this study, researchers want to look closely at what happens inside the body just before and during a migraine attack.

To do this, scientists use a medicine called cilostazol. This medicine widens blood vessels and can reliably trigger a temporary migraine-like headache in people who already live with migraines. By bringing on an attack in a safe medical clinic, researchers can observe the body's response in real time, measuring blood pressure, pulse, and symptoms over a 12-hour period.

The team is especially interested in how men and women experience these attacks. Migraines are far more common in women, meaning men are often underrepresented in research. Comparing both sexes helps scientists see if the biological triggers work in the same way for everyone.

Even though this trial will not cure your condition, it gives researchers vital clues about how migraines develop. In the long run, this knowledge can help pharmaceutical scientists design new, more targeted medicines to stop migraine attacks before they even begin.

Key takeaways

  • The study investigates how the drug cilostazol triggers migraine attacks in men and women.
  • Participants will receive either the study drug or an inactive dummy pill (placebo).
  • You will be monitored in a clinic for up to 12 hours to track your symptoms, heart rate, and blood pressure.
  • Proven pain-relief medications (ibuprofen or sumatriptan) are provided if you develop a migraine.
  • Joining does not cure migraines, but it helps scientists discover how to develop better medicines.

Who may be eligible?

This study is open to both men and women who are aged 18 or older and have a diagnosis of migraine without aura. A migraine without aura means your headaches happen without warning signs beforehand, such as seeing flashing lights, zigzag lines, or feeling pins and needles.

You may not be able to take part if you get migraines with aura, or if you have certain other health conditions, such as heart problems, severe high blood pressure, or a history of allergic reactions to painkillers like ibuprofen or sumatriptan.

The medical study team will check your full health history and perform basic tests to make sure that it is safe for you to join.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with migraines.
  3. My migraines occur without warning signs like flashing lights (no aura).
  4. I am generally in good health with no major heart conditions.
  5. I am able to spend up to 12 hours at the clinic for monitoring.
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be invited to a clinic visit where you will receive a single tablet. This will either be cilostazol or an inactive dummy pill (placebo). You will not know which tablet you have received until after the study.

You will stay at the clinic and be monitored closely for up to 12 hours. During this time, the medical team will measure your heart rate and blood pressure, especially during the first 90 minutes. They will also ask you to report any headache symptoms or other changes you feel.

If you develop a headache or migraine, the researchers will give you standard rescue medication—such as sumatriptan or ibuprofen—to relieve your pain safely before you go home.

Potential risks and benefits

This trial offers no direct medical benefit to your health, but it helps doctors better understand how migraines work so they can develop future treatments. The main risk is that the study medicine may trigger an unpleasant headache or migraine attack. You might also experience mild side effects like a racing heart, facial flushing, or stomach upset. You will be monitored by doctors the whole time and given pain-relief medication if an attack begins. Taking part is completely your choice, and you can change your mind and leave the study at any point without it affecting your everyday NHS care.

Locations (1)

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

Common questions

Why are researchers trying to trigger a migraine?

Because natural migraine attacks happen unpredictably, studying them in a lab is difficult. Safely triggering an attack in a clinic allows scientists to watch the exact biological changes from start to finish.

Will I have to endure severe pain without help?

No. The medical team will be with you throughout the visit and will provide effective rescue medicines, such as sumatriptan or ibuprofen, to treat your headache.

What is a placebo?

A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. It helps scientists confirm that the effects seen are truly caused by the study drug.

What does 'migraine without aura' mean?

It means your migraine attacks start without early sensory warning signs, such as seeing blind spots, zigzags, or feeling tingling in your hands or face.

Can I leave the study if I feel uncomfortable?

Yes. Participation is entirely voluntary. You can stop taking part at any time, for any reason, and your normal healthcare will continue as usual.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "The headache-inducing effects of cilostazol in men and women…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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