Clinical trial Recruiting at 3 sites Phase 2 Interventional Ages 18 to 80

Evaluating Amiloride for Preventing Migraine Aura

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

Run by Centre Hospitalier Universitaire de Nice · NCT04063540 · Data updated 2026-11-12

This study is testing if the medication amiloride can help prevent migraine aura in people who experience this type of migraine.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment40 (estimated)
SponsorCentre Hospitalier Universitaire de Nice
Academic / other
Locations5 sites (Bron and 4 other locations)
StatusRecruiting
StartedAugust 11, 2020
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedDecember 4, 2025
Trial IDNCT04063540 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals diagnosed with migraine with aura who experience at least one aura episode per month.

Probably not a fit

Patients with contraindications to amiloride or those currently on other prophylactic migraine treatments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy of amiloride, a non-selective blocker of Acid-Sensing Ion Channel-1, in preventing migraine with aura. It is a randomized crossover trial conducted at three headache centers in France, comparing the effects of amiloride against a placebo. The study aims to provide insights into the therapeutic potential of targeting Acid-Sensing Ion Channels in migraine management. Participants will be monitored for their response to the treatment over a specified period.

Why it matters

Potential benefit: If successful, this study could offer a new preventive treatment option for patients suffering from migraine with aura.

How similar studies have gone: While the approach of targeting Acid-Sensing Ion Channels is relatively novel, preliminary data suggest potential efficacy, but further validation is needed.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis of migraine with aura code
* At least 1 aura with aura per month in the 3 months prior to inclusion
* No prophylactic antimigraine treatment for at least 1 month prior to inclusion
* For women of childbearing age, use of a reliable contraceptive method at least 3 months before and 1 month after the study
* Signature of written informed consent
* Patient affiliated with Social Security

Exclusion Criteria:

* Existence of contraindication to taking amiloride:

  * Known hypersensitivity to the molecule
  * Hyperkalemia (potassium level (\> 5.5 mmol / l))
  * Use of another hyperkalemic diuretic or potassium salts
  * Renal insufficiency (clearance \<60 ml / min)
  * Severe hepatocellular insufficiency
  * In combination with lithium, converting enzyme inhibitors, angiotensin II inhibitors (except if there is hypokalemia), ciclosporin, tacrolimus, non-antiarrhythmic drugs giving torsades de pointes
* Cardiovascular and renal history, for subjects over 75 years old
* Patient, who from an investigator's point of view would not be compliant to the procedure of the study
* Pregnant or lactating patient
* Patient under trusteeship, under guardianship, protected by law

Where it's running

  • Ap-Hm
    Marly, France
    Recruiting
  • CHU de Montpellier
    Montpellier, France
    Recruiting
  • CHU de NICE
    Nice, France
    Recruiting
  • Hôpital Pierre Wertheimer
    Bron, France
    Not yet recruiting
  • CHU Gabriel Montpied
    Clermont-Ferrand, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Gepants for Acute Migraine in the Emergency Department

    This study tests whether rimegepant or zavegepant given in the ED can relieve an acute migraine for adults.

    Recruiting Phase 1 University of South Florida · Tampa, Florida · NCT07667621

  • Neurogenetics and cerebral blood flow in migraine with aura and patent foramen ovale

    This project will test whether adults with migraine with aura who have a patent foramen ovale (PFO) differ in specific genes, brain blood flow regulation, or platelet function from those without a PFO.

    Recruiting Azienda Usl di Bologna · Bologna, BO · NCT07349004

  • Triggering migraine aura with CGRP

    This trial will try giving calcitonin gene-related peptide (CGRP) to adults with migraine with aura to see if it triggers their aura.

    Recruiting Danish Headache Center · Glostrup Municipality · NCT07021859

  • Analyzing CGRP Levels in Migraine Patients by Age and Sex

    This study looks at the levels of a substance linked to migraines in people with migraines and healthy individuals to see how age and sex might affect treatment responses.

    Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT06674772

  • Evaluating migraine treatment effects using different designs

    This study is testing how different ways of giving treatment information affect the effectiveness of a migraine medication compared to a placebo in people with episodic migraines.

    Recruiting University of Aarhus · Aarhus C and 1 other locations · NCT06617832

  • Evaluating the effectiveness of rimegepant for preventing migraines

    This study is testing if taking a new migraine medication called rimegepant every other day can help people with frequent or chronic migraines feel better over two years.

    Recruiting at 2 sites University of Florence · Florence, Florence and 1 other locations · NCT06409832

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.