Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
Eligible age
18–80 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Centre Hospitalier Universitaire de Nice
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Source: ClinicalTrials.gov · NCT04063540 · last updated 2025-12-04