Status:
RECRUITING
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Migraine With Aura
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04063540
Start Date
August 11 2020
End Date
December 1 2027
Last Update
December 4 2025
Active Locations (5)
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1
Hôpital Pierre Wertheimer
Bron, France
2
CHU Gabriel Montpied
Clermont-Ferrand, France
3
AP-HM
Marly, France
4
CHU de Montpellier
Montpellier, France