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

Last updated: July 9, 2024
Sponsor: Centre Hospitalier Universitaire de Nice
Overall Status: Active - Recruiting

Phase

2

Condition

Migraine (Pediatric)

Oral Facial Pain

Migraine (Adult)

Treatment

Placebos

Amiloride

Clinical Study ID

NCT04063540
16-API-01
  • Ages 18-80
  • All Genders

Study Summary

Recent data suggest involvement of Acid-Sensing Ion Channel channels in the pathophysiology of migraine making these channels a therapeutic target of migraine disease. The implication of Acid-Sensing Ion Channels is discussed through Acid-Sensing Ion Channel-1 which is the most expressed Acid-Sensing Ion Channel channel subtype in the central nervous system. In a mouse model, cortical spreading depression is inhibited by different Acid-Sensing Ion Channel blockers including amiloride which is a non-selective blocker of the Acid-Sensing Ion Channel-1 channel. From a translational perspective, an efficacy of amiloride on a series of migraine patients suffering from severe aura in open conditions. The APAM study is a proof-of-concept study that aims to evaluate the effect of amiloride in the prophylaxis of migraine with aura. This is a randomized crossover study versus placebo conducted in 3 French headache centers.

Eligibility Criteria

Inclusion

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 3months before and 1 month after the study

  • Signature of written informed consent

  • Patient affiliated with Social Security

Exclusion

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 IIinhibitors (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 theprocedure of the study

  • Pregnant or lactating patient

  • Patient under trusteeship, under guardianship, protected by law

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebos
Phase: 2
Study Start date:
August 11, 2020
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Hôpital Pierre Wertheimer

    Bron,
    France

    Site Not Available

  • CHU Gabriel Montpied

    Clermont-Ferrand,
    France

    Site Not Available

  • AP-HM

    Marly,
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier,
    France

    Active - Recruiting

  • CHU de NICE

    Nice,
    France

    Active - Recruiting

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