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

• Status: Unknown status
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice
• Treatments: Amiloride

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