NCT04063540RecruitingPhase 2
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 19 Aug 2019
- Start date
- 11 Aug 2020
- Primary completion date
- Dec 2027
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Migraine
- NCT number
- NCT04063540
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 11 Aug 2020 to the primary completion date, Dec 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
Age
- Cardiovascular and renal history, for subjects over 75 years old
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Pierre Wertheimer Coordinator of this site? Confirm its status | Bron | France | Not yet recruiting |
| Chu Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Not yet recruiting |
| AP-HM Coordinator of this site? Confirm its status | Marly | France | Recruiting |
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.