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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Crossover
Treatments tested in this trial
Amiloride
DrugTreatment by Amiloride vs placebo in crossover
Placebos
DrugTreatment by Amiloride vs placebo in crossover
Treatment groups
Trial outcomes
Primary outcomes
Number of attacks with aura, with or without headache.
Secondary outcomes
Number of days with migraine headache, with or without aura
Functional repercussion
Anxiety and depression score on the Hospital Anxiety and Depression scale scale
Sponsors and contacts
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