RECRUITINGPhase 2INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - Patient affiliated with Social Security Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Amiloride

Treatment by Amiloride vs placebo in crossover

DRUG

Placebos

Treatment by Amiloride vs placebo in crossover

Locations (5)

Hôpital Pierre Wertheimer

Bron, France

CHU Gabriel Montpied

Clermont-Ferrand, France

AP-HM

Marly, France

CHU de Montpellier

Montpellier, France

CHU de NICE

Nice, France