Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
Recruiting · NCT04063540 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire de Nice
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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
Where it is running
10 locations listed.
- Hôpital Pierre Wertheimer - Bron, France
- Hôpital Pierre Wertheimer - Bron, France
- CHU Gabriel Montpied - Clermont-Ferrand, France
- CHU Gabriel Montpied - Clermont-Ferrand, France
- AP-HM - Marly, France
- AP-HM - Marly, France
- CHU de Montpellier - Montpellier, France
- CHU de Montpellier - Montpellier, France
- CHU de NICE - Nice, France
- CHU de NICE - Nice, France