RecruitingPHASE2INTERVENTIONAL

Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura

This research trial is investigating a new way to prevent migraine with aura. Scientists think that certain channels in the brain, called Acid-Sensing Ion Channels, play a part in causing migraines. In this study, they are testing a well-known medicine called amiloride, which has been shown to block these channels in laboratory tests. The main goal is to see if taking amiloride can effectively reduce or stop migraine aura episodes. This is a "proof-of-concept" study, meaning it's an early step to see if the idea works before larger trials. Participants will receive either amiloride or a placebo (a dummy pill) at different times, so researchers can compare the effects. It’s being carried out in France.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

Start

11 Aug 2020

Estimated completion

01 Dec 2027

Migraine With Aura

What is this study about?

Imagine your brain has tiny gates that let certain signals in and out. Scientists believe that some of these gates, called Acid-Sensing Ion Channels, might be overly active in people who get migraines with aura. When these gates are too active, they could contribute to the changes in the brain that lead to migraine attacks.

This study is trying to find out if a commonly used medicine called amiloride can help prevent these migraines. Amiloride is known to block these specific brain channels. Earlier tests in the lab, using models that mimic migraine, showed promising results, suggesting amiloride could stop the 'wave' of activity that causes aura symptoms. The researchers also saw some positive effects in a small group of migraine patients who took amiloride before this trial.

The main aim of this trial, called the APAM study, is to officially test whether amiloride really works to prevent migraine with aura. It’s a carefully designed study where participants will take either amiloride or a placebo (a pill with no active medicine) for a time, then switch. This allows doctors to compare the effects directly in each person, giving a clearer picture of whether amiloride is truly making a difference. This is an important step to see if this idea can help people living with migraine.

Key takeaways

Tests if amiloride can prevent migraine with aura.
Focuses on 'Acid-Sensing Ion Channels' in the brain.
Compares amiloride to a dummy pill (placebo).
Participation involves taking medication and tracking migraines.
It's an early-stage study (Phase 2) to see if the idea works.
Takes place in France and requires specific eligibility.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old and have a clear diagnosis of migraine with aura. You should also be experiencing aura at least once a month for the three months before the study starts. It's important that you haven't been taking other medicines to prevent migraines for at least a month before joining.

There are some reasons why you might not be able to take part. For example, if you are allergic to amiloride or have certain medical conditions like high potassium levels in your blood, kidney problems, or severe liver problems, you wouldn't be able to participate. You also shouldn't be taking certain other medicines that could react badly with amiloride. If you are pregnant, breastfeeding, or planning to become pregnant, you cannot join. Women who could become pregnant must use reliable birth control during and for a month after the study.

The research team also needs to make sure you're able to follow all the study instructions and attend appointments, and that it's safe for you to take the medication being tested. If you're elderly, they'll pay extra attention to your heart and kidney health.

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 between 18 and 80 years old?
Do you have a diagnosis of migraine with aura?
Do you experience at least one aura per month?
Have you stopped taking other migraine prevention medicines for at least a month?
Are you able to use reliable contraception if you're a woman who could get pregnant?
Do you have any conditions like severe kidney/liver problems or high potassium levels?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in the study for a period of time, though the exact duration isn't specified, it usually lasts several months. You will visit one of the headache centres in France for appointments. During these visits, doctors will assess your migraine symptoms and general health. You'll be given either amiloride or a placebo (a dummy pill) to take, and then after a break, you'll switch to the other treatment. This is called a crossover study. You'll need to keep a record of your migraine attacks and any aura you experience. There will be regular check-ups to monitor your health and how you're responding to the treatment. You will also need to follow specific instructions about contraception if you are a woman of childbearing age.

Potential risks and benefits

Taking part in a clinical trial means you might experience some benefits, such as receiving close medical attention for your migraines. You may also find that amiloride helps to reduce your migraine aura, though this is not guaranteed, as the treatment might not work for everyone, or you might receive the placebo for part of the study. There are also potential risks; amiloride can have side effects, and some of these could be serious, especially if you have existing health conditions. These will be explained in detail before you agree to participate. You will be monitored closely for any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Hôpital Pierre Wertheimer
Verified postcode
Bron, France· Not yet recruiting
CHU Gabriel Montpied
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
AP-HM
Verified postcode
Marly, France· Recruiting
CHU de Montpellier
Verified postcode
Montpellier, France· Recruiting
CHU de NICE
Verified postcode
Nice, France· Recruiting

Common questions

What is 'migraine with aura'?

Migraine with aura means you have sensory disturbances like flashing lights or numbness before your migraine headache begins.

What is amiloride?

Amiloride is a medicine currently used for other conditions, often related to blood pressure or fluid retention, that also affects certain brain channels.

What does 'crossover study' mean?

It means you'll take one medicine (amiloride or placebo) for a period, then switch to the other. Everyone tries both at different times.

Will I know if I'm taking the real medicine or the placebo?

No, this is a 'blinded' study. Neither you nor your doctor will know which treatment you are on until after the study ends.

Is this study happening in the UK?

No, this particular study is being carried out in three headache centres in France.

How to find out more

Michel LANTERI-MINET, Dr

lanteri-minet.m@chu-nice.fr 04 92 03 76 46 Official trial record

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