跳至主要内容
临床试验/EUCTR2017-001288-18-FR
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

CHU de Nice0 个研究点目标入组 40 人开始时间: 2018年11月6日最近更新:
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

发起方
CHU de Nice

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