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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
StatusRecruiting
PhasePhase 2
Started2020-08-11
View on ClinicalTrials.gov ↗

Amendment history

2025-11-27
minor
Study Status v3
Primary completion date2025-12→2027-12
Completion date2025-12→2027-12
2024-07-09
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2019-11→2025-12
Completion date2021-11→2025-12
Start dateestimated 2019-11→confirmed 2020-08-11
Study sites2→5
2019-08-20
minor
Study Identification, Study Status, Study Description, Conditions, Outcome Measures, Eligibility v1
Eligibility criteria+16 characters
[...] e hepatocellular insufficiency In combination with lithium, ACEconverting enzyme inhibitors, angiotensin II inhibitors (except if there is h [...] re of the study Pregnant or lactating patient Patient under tutorshiptrusteeship, under guardianship, protected by law
Secondary endpointsdetails revised at 1 of 2 entries
Study title+11 characters
ASICAcid-Sensing ChannelsIon Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
2019-08-19
minor
Original filing
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.
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