[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100367381":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":99,"collaborators":24,"id":101,"slug":24,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":24,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":68,"whyStopped":24,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Nice","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"placebo-amiloride","Patients will be treated for 12 weeks with placebo and then after a 4 week wash-out period, will be treated for 12 weeks with amiloride.",[12,13],"Drug: Amiloride","Drug: Placebos",{"label":15,"type":6,"description":16,"interventionNames":17},"amiloride -placebo","Patients will be treated for 12 weeks with amiloride and then after a 4 week wash-out period, will be treated for 12 weeks with placebo.",[12,13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Amiloride","Treatment by Amiloride vs placebo in crossover",[15,9],null,{"type":20,"name":26,"description":22,"armGroupLabels":27,"otherNames":24},"Placebos",[15,9],[29],{"name":30,"affiliation":5,"role":31},"Michel LANTERI-MINET, Dr","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","04 92 03 76 46","lanteri-minet.m@chu-nice.fr",{"name":38,"role":34,"phone":24,"phoneExt":24,"email":39},"sylvie ROMETTINO","romettino.s@chu-nice.fr",[41,55,66,78,89],{"facility":42,"status":43,"city":44,"state":24,"zip":24,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Hôpital Pierre Wertheimer","NOT_YET_RECRUITING","Bron","France",{"type":47,"coordinates":48},"Point",[49,50],4.91303,45.73865,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":24,"phoneExt":24,"email":24},"Geneviève DEMARQUAY, Dr",{"facility":56,"status":43,"city":57,"state":24,"zip":24,"country":45,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"CHU Gabriel Montpied","Clermont-Ferrand",{"type":47,"coordinates":59},[60,61],3.08682,45.77969,{"lat":61,"lon":60},[64],{"name":65,"role":34,"phone":24,"phoneExt":24,"email":24},"Xavier MOISSET, Dr",{"facility":67,"status":68,"city":69,"state":24,"zip":24,"country":45,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"AP-HM","RECRUITING","Marly",{"type":47,"coordinates":71},[72,73],3.54959,50.34556,{"lat":73,"lon":72},[76],{"name":77,"role":34,"phone":24,"phoneExt":24,"email":24},"Anne DONNET, Dr",{"facility":79,"status":68,"city":80,"state":24,"zip":24,"country":45,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"CHU de Montpellier","Montpellier",{"type":47,"coordinates":82},[83,84],3.87635,43.61093,{"lat":84,"lon":83},[87],{"name":88,"role":34,"phone":24,"phoneExt":24,"email":24},"Anne DUCROS, Pr",{"facility":90,"status":68,"city":91,"state":24,"zip":24,"country":45,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"CHU de NICE","Nice",{"type":47,"coordinates":93},[94,95],7.26608,43.70313,{"lat":95,"lon":94},[98],{"name":30,"role":34,"phone":24,"phoneExt":24,"email":24},{"type":100,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100367381",false,"NCT04063540","Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura","APAM","Inclusion Criteria:\n\n* Diagnosis of migraine with aura code\n* At least 1 aura with aura per month in the 3 months prior to inclusion\n* No prophylactic antimigraine treatment for at least 1 month prior to inclusion\n* For women of childbearing age, use of a reliable contraceptive method at least 3 months before and 1 month after the study\n* Signature of written informed consent\n* Patient affiliated with Social Security\n\nExclusion Criteria:\n\n* Existence of contraindication to taking amiloride:\n\n  * Known hypersensitivity to the molecule\n  * Hyperkalemia (potassium level (\\> 5.5 mmol \u002F l))\n  * Use of another hyperkalemic diuretic or potassium salts\n  * Renal insufficiency (clearance \\\u003C60 ml \u002F min)\n  * Severe hepatocellular insufficiency\n  * In combination with lithium, converting enzyme inhibitors, angiotensin II inhibitors (except if there is hypokalemia), ciclosporin, tacrolimus, non-antiarrhythmic drugs giving torsades de pointes\n* Cardiovascular and renal history, for subjects over 75 years old\n* Patient, who from an investigator's point of view would not be compliant to the procedure of the study\n* Pregnant or lactating patient\n* Patient under trusteeship, under guardianship, protected by law","ALL","18 Years","80 Years",{"count":111,"type":112},40,"ESTIMATED","INTERVENTIONAL",[115],"PHASE2","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.",[118],"Migraine With Aura",[120,121,21,122],"migraine","aura","acid-sensing ion channel","2025-11-27",{"date":125,"type":126},"2025-12-04","ACTUAL",{"date":128,"type":126},"2020-08-11",{"date":130,"type":112},"2027-12",{"name":5,"class":6},5]