Actively Recruiting
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-12-04
40
Participants Needed
5
Research Sites
381 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of migraine with aura
- Experience at least 1 migraine aura per month over the 3 months before joining
- No preventive migraine treatment for at least 1 month before joining
- Women of childbearing age must use reliable contraception from 3 months before until 1 month after the study
- Signed written informed consent
- Affiliated with Social Security
You will not qualify if you...
- Allergy or known hypersensitivity to amiloride
- High potassium level (above 5.5 mmol/l)
- Use of other potassium-increasing diuretics or potassium supplements
- Kidney failure with clearance below 60 ml/min
- Severe liver failure
- Use of lithium, certain blood pressure medicines, ciclosporin, tacrolimus, or drugs causing heart rhythm problems
- History of heart or kidney problems if over 75 years old
- Likely non-compliance with study procedures
- Pregnancy or breastfeeding
- Under legal protection such as guardianship or trusteeship
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Hôpital Pierre Wertheimer
Bron, France
Not Yet Recruiting
2
CHU Gabriel Montpied
Clermont-Ferrand, France
Not Yet Recruiting
3
AP-HM
Marly, France
Actively Recruiting
4
CHU de Montpellier
Montpellier, France
Actively Recruiting
5
CHU de NICE
Nice, France
Actively Recruiting
Research Team
M
Michel LANTERI-MINET, Dr
CONTACT
S
sylvie ROMETTINO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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