Evaluating Amiloride for Preventing Migraine Aura

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

This study is testing if the medication amiloride can help prevent migraine aura in people who experience this type of migraine.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nice (other)
• Locations: 5 sites (Bron and 4 other locations)
• Trial ID: NCT04063540 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy of amiloride, a non-selective blocker of Acid-Sensing Ion Channel-1, in preventing migraine with aura. It is a randomized crossover trial conducted at three headache centers in France, comparing the effects of amiloride against a placebo. The study aims to provide insights into the therapeutic potential of targeting Acid-Sensing Ion Channels in migraine management. Participants will be monitored for their response to the treatment over a specified period.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with migraine with aura who experience at least one aura episode per month.

Not a fit: Patients with contraindications to amiloride or those currently on other prophylactic migraine treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new preventive treatment option for patients suffering from migraine with aura.

How similar studies have performed: While the approach of targeting Acid-Sensing Ion Channels is relatively novel, preliminary data suggest potential efficacy, but further validation is needed.

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

Where this trial is running

Bron and 4 other locations

• Hôpital Pierre Wertheimer — Bron, France (NOT_YET_RECRUITING)
• CHU Gabriel Montpied — Clermont-Ferrand, France (NOT_YET_RECRUITING)
• AP-HM — Marly, France (RECRUITING)
• CHU de Montpellier — Montpellier, France (RECRUITING)
• CHU de NICE — Nice, France (RECRUITING)

Study contacts

• Principal investigator: Michel LANTERI-MINET, Dr — Centre Hospitalier Universitaire de Nice
• Study coordinator: Michel LANTERI-MINET, Dr

Conditions: Migraine With Aura, migraine, aura, Amiloride, acid-sensing ion channel