Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

The headache-inducing effects of sildenafil in men and women with episodic migraine without aura.

This research wants to understand if sildenafil, a medicine often known for treating erectile dysfunction, might cause or change migraine headaches in people who regularly experience migraines without aura. The study focuses on both men and women. Researchers will compare how often migraine-like headaches happen in people taking sildenafil versus those taking a dummy pill (placebo). They will also look at whether sildenafil affects other types of headaches, heart rate, blood pressure, and any unwanted side effects, comparing it to standard migraine treatments like Ibuprofen and Sumatriptan. This will help doctors understand more about how sildenafil interacts with migraine.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Syddansk Universitet (University of Southern Denmark)

Enrolment target

Start

03 Aug 2024

Migraine without aura

What is this study about?

This study is investigating something interesting: whether a medicine called sildenafil, which is well-known for treating erectile dysfunction and sometimes used for high blood pressure in the lungs, affects migraines. Specifically, it's looking at people who get migraines without 'aura' – that's the flashing lights or other warning signs some people get before a migraine.

The main goal is to see if taking sildenafil causes more migraine-like headaches to happen compared to taking a dummy pill (called a placebo). They're studying both men and women with this type of migraine. They will also be comparing sildenafil's effects with common migraine treatments like Ibuprofen and Sumatriptan.

Beyond just migraines, the researchers will also be checking for differences in general headaches, monitoring participants' heart rate and blood pressure, and keeping a close eye on any side effects. This kind of research helps us learn more about how different medicines can affect the body, especially in people with existing conditions like migraine.

Key takeaways

This study investigates sildenafil's effect on migraines.
It's for adults, male and female, with migraines without aura.
Compares sildenafil to a dummy pill and other migraine drugs.
Looks at headache frequency, heart rate, blood pressure, and side effects.
Participation helps further understanding of migraine treatments.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Since the study is about migraines without aura, you must experience this specific type of migraine regularly. This will likely be confirmed by the study doctors based on your medical history.

There might be other health conditions or medications that would prevent you from taking part, but these are the main points. The study team will check carefully if you're a good fit.

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.

Are you 18 years old or older?
Do you experience migraines without aura?
Are you able to attend study visits regularly?
Are you willing to potentially take different medications, including a dummy pill?
Are you ready to report your headaches and symptoms?

Answer every question to see your result.

What does participation involve?

If you take part, you would likely have several visits to a clinic over a period of time. During these visits, you’d be given different medications to take, which could include sildenafil, a dummy pill, Ibuprofen, or Sumatriptan. You might not know which one you are taking at certain times.

Medical staff will regularly check your health, which might include measuring your heart rate and blood pressure. You will also be asked to report any headaches or other symptoms you experience, probably by keeping a diary. The total duration of your involvement in the study would be explained to you before you agree to take part.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to our understanding of migraine and how certain medications affect it, which could help future patients. However, there's no guarantee it will directly benefit your own migraines. Potential risks might include experiencing side effects from the study medications, as all medicines can have unwanted effects. You might also find that one of the study drugs temporarily makes your headaches worse. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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 sildenafil?

Sildenafil is a medicine known for treating erectile dysfunction. It's also used to treat a condition called pulmonary hypertension, which is high blood pressure in the arteries of the lungs.

What does 'migraine without aura' mean?

'Migraine without aura' means you get migraine headaches but you don't experience the warning signs that some people get, like flashing lights, zigzag lines, or numbness, beforehand.

What is a 'placebo'?

A placebo is a 'dummy pill' that looks exactly like the real medicine but contains no active drug. It helps researchers see if the effects are truly from the medicine or just from expectation.

Will I know which medication I am taking?

In studies like this, you often won't know whether you are taking the active drug or a placebo at different times. This is called 'blinding' and helps ensure unbiased results.

What other medicines are involved?

The study also involves common migraine treatments like Ibuprofen (a painkiller) and Sumatriptan (a specific migraine drug) to compare effects.