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NCT Number: NCT04063540

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Pierre Wertheimer, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amiloride

Drug

Treatment by Amiloride vs placebo in crossover

Placebos

Drug

Treatment by Amiloride vs placebo in crossover

Primary outcomes

  1. Number of attacks with aura, with or without headache.

    Time frame: 12 weeks

Secondary outcomes

  1. Number of days with migraine headache, with or without aura

    Time frame: 12 weeks

  2. Functional repercussion

    Time frame: 12 weeks

    Anxiety and depression score on the Hospital Anxiety and Depression scale scale

Study contacts

Contact information is provided by the study sponsor or research team.

Michel LANTERI-MINET, Dr

CONTACT

[email protected]

04 92 03 76 46

sylvie ROMETTINO

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: APAM

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2019
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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