Migraine With Aura
Conditions
Keywords
migraine, aura, Amiloride, acid-sensing ion channel
Brief summary
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
DRUGAmiloride
Treatment by Amiloride vs placebo in crossover
DRUGPlacebos
Treatment by Amiloride vs placebo in crossover
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of attacks with aura, with or without headache. | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days with migraine headache, with or without aura | 12 weeks | — |
| Functional repercussion | 12 weeks | Anxiety and depression score on the Hospital Anxiety and Depression scale scale |
Countries
France
Contacts
Primary ContactMichel LANTERI-MINET, Dr
Backup Contactsylvie ROMETTINO
Outcome results
None listed