Tests amiloride to prevent migraine attacks with aura
Tests amiloride against placebo in adults with migraine with aura.
Plain-language title generated from the registry record
Registry title: Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
Key facts
- Where
- Bron, Clermont-Ferrand, Marly, Montpellier, and Nice, FranceSee the 5 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04063540, who can take part
Where in France
- Hôpital Pierre WertheimerBron, FranceNot yet recruiting
- Chu Gabriel MontpiedClermont-Ferrand, FranceNot yet recruiting
- AP-HMMarly, FranceTaking people
- CHU de MontpellierMontpellier, FranceTaking people
- CHU de NiceNice, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire de Nice
- Trial code
- NCT04063540
- Record updated
- 4 December 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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.