[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100367381":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":100,"collaborators":24,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":24,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"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",[41,56,67,79,90],{"facility":42,"status":43,"city":44,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hôpital Pierre Wertheimer","NOT_YET_RECRUITING","Bron","France","FR",{"type":48,"coordinates":49},"Point",[50,51],4.91303,45.73865,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":24,"phoneExt":24,"email":24},"Geneviève DEMARQUAY, Dr",{"facility":57,"status":43,"city":58,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"CHU Gabriel Montpied","Clermont-Ferrand",{"type":48,"coordinates":60},[61,62],3.08682,45.77969,{"lat":62,"lon":61},[65],{"name":66,"role":34,"phone":24,"phoneExt":24,"email":24},"Xavier MOISSET, Dr",{"facility":68,"status":69,"city":70,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"AP-HM","RECRUITING","Marly",{"type":48,"coordinates":72},[73,74],3.54959,50.34556,{"lat":74,"lon":73},[77],{"name":78,"role":34,"phone":24,"phoneExt":24,"email":24},"Anne DONNET, Dr",{"facility":80,"status":69,"city":81,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"CHU de Montpellier","Montpellier",{"type":48,"coordinates":83},[84,85],3.87635,43.61093,{"lat":85,"lon":84},[88],{"name":89,"role":34,"phone":24,"phoneExt":24,"email":24},"Anne DUCROS, Pr",{"facility":91,"status":69,"city":92,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"CHU de NICE","Nice",{"type":48,"coordinates":94},[95,96],7.26608,43.70313,{"lat":96,"lon":95},[99],{"name":30,"role":34,"phone":24,"phoneExt":24,"email":24},{"type":101,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100367381","phase-2-acid-sensing-ion-channel-and-migraine-disease-proof-of-concept-study-on-the-efficacy-of-amiloride-in-the-prophylaxis-of-migraine-aura-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":113,"type":114},40,"ESTIMATED","INTERVENTIONAL",[117],"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.",[120],"Migraine With Aura",[122,123,21,124],"migraine","aura","acid-sensing ion channel","2025-11-27",{"date":127,"type":128},"2025-12-04","ACTUAL",{"date":130,"type":128},"2020-08-11",{"date":132,"type":114},"2027-12",{"name":5,"class":6},5]