Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Aug 19, 2019

Keywords

ClinConnect Summary

This clinical trial, called the APAM study, is looking at the potential benefits of a medication called amiloride for people who experience migraines with aura. An aura can involve visual disturbances or other sensory changes that occur before or during a migraine headache. The trial is based on research suggesting that specific channels in the brain may play a role in migraines, and amiloride is thought to help by blocking those channels. The study will take place in three headache centers in France and will involve participants trying both the medication and a placebo (an inactive substance) in a random order.

To participate in this trial, individuals must be diagnosed with migraines with aura and have experienced at least one aura per month in the last three months. They should not have taken any migraine prevention medication for at least a month before joining the study. Participants will be asked to provide informed consent and meet certain health criteria to ensure their safety. Throughout the trial, participants will receive careful monitoring to assess how well amiloride works in reducing the frequency or severity of their migraine auras. If you're interested in participating or want to know more, it's best to reach out to the study centers for further details.

Gender

ALL

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