EUCTR2017-001288-18-FR招募中1 期
ASIC channels and migraine disorders - Proof of concept study on the efficacy of Amiloride in prophylaxis of Migraine with Aura - APAM study - APAM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- CHU de Nice
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Subjects aged 18 to 80 years
- •- Male or female
- •- Diagnosis of migraine with aura code 1.2.1 according to ICHD-3 including codes 1.2.1.1.1 and 1.2.1.2
- •- At least 1 crisis with aura per month in the 3 months prior to inclusion
- •- No prophylactic migraine background treatment for at least 1 month before inclusion
- •- For women of childbearing age, use of a reliable contraceptive method at least 3 months before and 1 month after the study
- •- Signing of written informed consent
- •- Patient affiliated to social security
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Existence of contraindications to taking amiloride:
- •- Known hypersensitivity to the molecule
- •- Hyperkalemia
- •- Use of another hyperkalemic diuretic or potassium salts
- •- Renal insufficiency (clearance < 60 ml/min)
- •- Severe hepatocellular insufficiency
- •- Patient, who from the investigator's point of view would not be compliant with the study procedure
- •- Pregnant or breastfeeding patient
- •- Patient under guardianship, protected by law
研究者
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