AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

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

This research is investigating a medicine called pitolisant to understand its effects, specifically if it can cause headaches or migraine attacks in women who regularly experience migraines without aura. The study compares pitolisant to a dummy pill (placebo) and other common migraine treatments like ibuprofen and sumatriptan. Scientists will observe whether women experience migraine-like attacks after taking pitolisant or the placebo. They will also measure how severe any headaches are over time and if any headache occurs, not just migraines. This is an early-stage study, combining Phase I and Phase II, to learn more about the drug's effects.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Syddansk Universitet (University of Southern Denmark)

Enrolment target

Start

26 Mar 2026

Migraine without aura

What is this study about?

This study is about a medicine called pitolisant. Researchers are trying to understand how it affects headaches and migraines in women who already have migraines but don't experience the visual changes (aura) that some people get before a migraine. They want to find out if taking pitolisant can actually cause more migraine-like headaches compared to a sugar pill (called a placebo) or other medicines often used for migraines, like ibuprofen or sumatriptan.

The main thing the scientists are looking for is whether women experience migraine attacks after taking pitolisant or the placebo. They're also interested in how strong any headaches are over time, not just the full-blown migraines. This will help them understand the drug's effects on different types of headaches.

This kind of research is really important because it helps us learn more about new medicines. By carefully comparing pitolisant to a placebo and standard treatments, doctors can get a clearer picture of its potential impact on people with migraines. This information helps healthcare professionals make informed decisions about future treatments.

Key takeaways

This study looks at how a new medicine, pitolisant, affects headaches and migraines.
It's for women who get migraines but don't experience auras.
Researchers are comparing pitolisant to a dummy pill and common migraine drugs.
The main goal is to see if pitolisant causes more migraine-like attacks.
Participation could help improve our understanding of migraine treatments.

Who may be eligible?

To be able to join this study, you must be a woman. You need to be at least 18 years old, but there's no upper age limit mentioned. Importantly, you must have migraines that do not include an 'aura' – this means you don't get the warning signs like flashing lights or blind spots before your migraine starts.

If you have headaches that are not migraines, or if your migraines always come with an aura, this study might not be suitable for you. The researchers are specifically looking for women whose migraines typically don't have this aura component.

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.
I am 18 years old or older.
I have migraines that do NOT include an aura (no visual changes like flashing lights before the headache).
I understand I will be taking one of several possible medicines, including a dummy pill.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to take a specific medicine: pitolisant, a dummy pill (placebo), ibuprofen, or sumatriptan. The study will be spread out over several visits, during which researchers will closely monitor any headaches you experience. You might need to keep a diary of your headaches. The total duration of your participation will depend on the study design, but it usually involves a series of check-ups and follow-up assessments over a period of time.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from taking the study medicine, but your involvement could help us learn more about migraines for others. There's a chance you might experience side effects from the trial medicines, including headaches, but these will be carefully monitored. You'll be given detailed information about all possible risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your 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 'migraine without aura'?

Migraine without aura means you get migraine headaches but don't have visual changes, like flashing lights, before the headache starts.

What is pitolisant?

Pitolisant is a medicine being studied to understand its effects on headaches and migraines in this research.

What is a 'placebo'?

A placebo is a dummy pill that looks like the real medicine but doesn't contain any active drug. It helps researchers see if the real medicine is actually having an effect.

Will I know which medicine I'm taking?

Often in these types of studies, participants don't know whether they are receiving the study drug or a placebo until the study is over. This is called 'blinding' and it helps make the results more reliable.

How long will the study last?

The information provided doesn't state the exact length, but clinical trials usually involve a period of treatment, observation, and follow-up visits.