Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amiloride, Placebos.
- Who it may be relevant to
- Registry conditions: Migraine With Aura. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Amiloride
Treatment by Amiloride vs placebo in crossover - Drug Placebos
Treatment by Amiloride vs placebo in crossover
Primary outcome measures
- Number of attacks with aura, with or without headache. [Time frame: 12 weeks]
Secondary outcome measures (2)
- Number of days with migraine headache, with or without aura [Time frame: 12 weeks]
- Functional repercussion [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- Diagnosis of migraine with aura code
- At least 1 aura with aura per month in the 3 months prior to inclusion
- No prophylactic antimigraine treatment for at least 1 month prior to inclusion
- For women of childbearing age, use of a reliable contraceptive method at least 3 months before and 1 month after the study
- Signature of written informed consent
- Patient affiliated with Social Security
Exclusion criteria
- Existence of contraindication to taking amiloride:
- Known hypersensitivity to the molecule
- Hyperkalemia (potassium level (> 5.5 mmol / l))
- Use of another hyperkalemic diuretic or potassium salts
- Renal insufficiency (clearance <60 ml / min)
- Severe hepatocellular insufficiency
- In combination with lithium, converting enzyme inhibitors, angiotensin II inhibitors (except if there is hypokalemia), ciclosporin, tacrolimus, non-antiarrhythmic drugs giving torsades de pointes
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 5 centers
- Hôpital Pierre Wertheimer — Bron
- CHU Gabriel Montpied — Clermont-Ferrand
- AP-HM — Marly
- CHU de Montpellier — Montpellier
- CHU de NICE — Nice
Publications
- 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. PMID 24042483
- 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. PMID 16450381
- 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. PMID 16611468
Identifiers
NCT: NCT04063540 · 16-API-01