Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Number of attacks with aura, with or without headache.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
amiloride -placebo
Patients will be treated for 12 weeks with amiloride and then after a 4 week wash-out period, will be treated for 12 weeks with placebo.
干预措施: Placebos (Drug)
placebo-amiloride
Patients will be treated for 12 weeks with placebo and then after a 4 week wash-out period, will be treated for 12 weeks with amiloride.
干预措施: Amiloride (Drug)
placebo-amiloride
Patients will be treated for 12 weeks with placebo and then after a 4 week wash-out period, will be treated for 12 weeks with amiloride.
干预措施: Placebos (Drug)
amiloride -placebo
Patients will be treated for 12 weeks with amiloride and then after a 4 week wash-out period, will be treated for 12 weeks with placebo.
干预措施: Amiloride (Drug)
结局指标
主要结局
Number of attacks with aura, with or without headache.
时间窗: 12 weeks
次要结局
- Functional repercussion(12 weeks)
- Number of days with migraine headache, with or without aura(12 weeks)