Clinical Trial

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

Study acronym: APAM
Recruiting Phase 2
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2019-08-19; most recent amendment 2025-11-27.
Status change: Not Yet Recruiting → Recruiting 2024-07-09
Trial Details
NCT Number NCT04063540
Lead Sponsor Centre Hospitalier Universitaire de Nice
Conditions Migraine With Aura
Enrollment 40 participants
Start Date 2020-08-11
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-04