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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo-amiloride | Other | 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. |
|
| amiloride -placebo | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amiloride | Drug | Treatment by Amiloride vs placebo in crossover |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of attacks with aura, with or without headache. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days with migraine headache, with or without aura | 12 weeks | |
| Functional repercussion | Anxiety and depression score on the Hospital Anxiety and Depression scale scale | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Existence of contraindication to taking amiloride:
Cardiovascular and renal history, for subjects over 75 years old
Patient, who from an investigator's point of view would not be compliant to the procedure of the study
Pregnant or lactating patient
Patient under trusteeship, under guardianship, protected by law
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel LANTERI-MINET, Dr | Contact | 04 92 03 76 46 | lanteri-minet.m@chu-nice.fr | |
| sylvie ROMETTINO | Contact | romettino.s@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| Michel LANTERI-MINET, Dr | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pierre Wertheimer | Not yet recruiting | Bron | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24042483 | Background | Charles AC, Baca SM. Cortical spreading depression and migraine. Nat Rev Neurol. 2013 Nov;9(11):637-44. doi: 10.1038/nrneurol.2013.192. Epub 2013 Sep 17. | |
| 16450381 | Result | Ayata C, Jin H, Kudo C, Dalkara T, Moskowitz MA. Suppression of cortical spreading depression in migraine prophylaxis. Ann Neurol. 2006 Apr;59(4):652-61. doi: 10.1002/ana.20778. |
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| Placebos | Drug | Treatment by Amiloride vs placebo in crossover |
|
| CHU Gabriel Montpied | Not yet recruiting | Clermont-Ferrand | France |
|
| AP-HM | Recruiting | Marly | France |
|
| CHU de Montpellier | Recruiting | Montpellier | France |
|
| CHU de NICE | Recruiting | Nice | France |
|
| 16611468 | Result | Ligthart L, Boomsma DI, Martin NG, Stubbe JH, Nyholt DR. Migraine with aura and migraine without aura are not distinct entities: further evidence from a large Dutch population study. Twin Res Hum Genet. 2006 Feb;9(1):54-63. doi: 10.1375/183242706776403019. |
| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| D008881 | Migraine Disorders |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000584 | Amiloride |
| ID | Term |
|---|---|
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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