Informations générales (source: ClinicalTrials.gov)
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura (APAM)
Interventional
Phase 2
Centre Hospitalier Universitaire de Nice (Voir sur ClinicalTrials)
août 2020
décembre 2025
11 juillet 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Montpellier - Montpellier - France | Anne DUCROS, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM - Marly - France | Anne DONNET, Dr | Contact (sur clinicalTrials) | |||
| CHU de NICE - Nice - France | Michel LANTERI-MINET, Dr | Contact (sur clinicalTrials) | |||
| CHU Gabriel Montpied - Clermont-Ferrand - France | Xavier MOISSET, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Pierre Wertheimer - Bron - France | Geneviève DEMARQUAY, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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