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Study of Amiloride tablets for prevention of migraine with aura attacks

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with migraine with aura, a specific type of headache condition where visual or other neurological symptoms occur before or during the headache. The research examines the effectiveness of amiloride, a medication that blocks certain channels in the brain, to prevent migraine aura from occurring.

The study will test whether taking amiloride tablets can reduce the frequency of migraine attacks with aura. The medication will be taken orally each day for three months, with a maximum daily dose of 10 mg. The total amount of medication received during the entire study period will not exceed 900 mg.

The research aims to understand if blocking specific brain channels with amiloride can help prevent the occurrence of migraine aura symptoms. During the study, participants will need to track their migraine episodes and any changes in their condition. The study will also monitor how the treatment affects daily activities and overall well-being.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase

    You will receive Modamide tablets containing 5 mg of amiloride for oral use

    The treatment aims to prevent migraine auras - visual or sensory disturbances that occur before or during migraine headaches

    The study will evaluate how well amiloride works in reducing the frequency of migraine auras

  2. Step 2

    Treatment monitoring

    Your progress will be tracked by recording:

    - Number of migraine auras you experience, with or without headache

    - Number of days you have migraine headaches

    - Number of days you have any type of headache

    You will complete several questionnaires to assess:

    - How migraines affect your daily activities (using HIT-6 scale)

    - Your emotional well-being (using HAD scale)

    - Your overall health status (using EQ-5D scale)

  3. Step 3

    Safety monitoring

    Any unusual symptoms or side effects you experience will be documented

    If you are a woman of childbearing age, you must use reliable contraception during the study and for one month after

    The study duration may extend until December 2025

  4. Step 4

    Important requirements

    You must have experienced at least one migraine with aura per month in the previous 3 months

    You cannot be taking other migraine prevention medications during the study

    You must be between 18 and 80 years old

    You must have social security coverage

Who can join the trial?

8 criteria

  • Age between 18 and 80 years old
  • Can be either male or female
  • Must have a confirmed diagnosis of migraine with aura (a condition where headaches are preceded by sensory disturbances like flashing lights, blind spots, or tingling sensations)
  • Must experience at least 1 migraine with aura attack per month in the past 3 months
  • Must not have used any preventive migraine medications for at least 1 month before joining the study
  • Women who can become pregnant must use reliable contraception for at least 3 months before and 1 month after the study
  • Must be willing to sign an informed consent form to participate in the study
  • Must have active social security coverage

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years
  • Pregnancy or breastfeeding
  • History of allergic reactions to amiloride (the study medication) or similar drugs
  • Current use of medications that could interact with amiloride
  • Severe kidney or liver problems
  • Uncontrolled high blood pressure
  • History of heart disease or heart rhythm problems
  • Other types of headaches that could be confused with migraines
  • Participation in another clinical trial within the last 30 days
  • Mental health conditions that could affect the ability to provide informed consent
  • History of substance abuse within the past year
  • Inability to follow study procedures or attend scheduled visits
  • Medical conditions that could interfere with the evaluation of the study medication
  • Use of other migraine prevention medications that cannot be safely stopped
  • History of stroke or other serious neurological conditions
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Investigated drugs

Amiloride is a medication that works by blocking specific channels in nerve cells called ASIC-1 channels. It is primarily used to treat high blood pressure and heart conditions, but in this trial, it is being studied as a preventive treatment for migraine auras. Migraine auras are sensory disturbances that some people experience before a migraine headache begins, such as seeing flashing lights or experiencing numbness. The medication aims to reduce the frequency and severity of these aura symptoms by regulating the activity of nerve cells in the brain.

What is already known about the treatment

Amiloride – A potassium-sparing diuretic medication that also functions as a non-specific ASIC-1 channel blocker, typically administered orally in tablet form. This medication has been traditionally used to treat high blood pressure and heart failure, but is now being investigated for its potential role in preventing migraine auras through its ability to block acid-sensing ion channels (ASICs) in the brain. Amiloride works at the molecular level by inhibiting sodium channels in the kidneys and blocking ASIC-1 channels, which are believed to play a role in neurological conditions including migraines. The medication belongs to the pharmacological class of diuretics and ion channel blockers, and its potential expansion into migraine prevention represents an innovative approach in neurological medicine.

Investigated diseases

Migraine with aura - A neurological condition characterized by recurring headaches preceded by sensory disturbances called aura. The aura typically involves visual symptoms such as flashing lights, zigzag lines, or blind spots, but can also include other sensory changes. These warning symptoms usually develop gradually over several minutes and can last up to an hour before the headache begins. The headache phase is often accompanied by sensitivity to light and sound, nausea, and may affect one or both sides of the head. Episodes can last from several hours to days, with varying frequency among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-516044-25-00Protocol code16-API-01Estimated enrolment40 patientsSponsorCentre Hospitalier Universitaire De Nice

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