NCT04574713已完成2 期
Candesartan for Migraine Prevention: A Multicentre, Binational, Triple Blind, Placebo Controlled, Parallel Group Study of Two Doses of Candesartan (8 and 16 mg)
St. Olavs Hospital10 个研究点 分布在 2 个国家目标入组 450 人开始时间: 2021年4月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 10
- 主要终点
- change in number of migraine days per 4 weeks, from baseline
研究概览
简要总结
The main objective of this study is to see whether the favorable preventative effect of candesartan 16 mg per day in episodic migraine, that was found previously in two smaller randomized controlled cross-over studies, can be confirmed in a larger, multicenter, randomized controlled parallel group study. In addition it will be investigated whether 1) also a smaller dose of 8 mg is effective, and 2) whether the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Episodic migraine with or without aura according to ICHD-3 criteria
- •At inclusion, patients should retrospectively have from 2 to 8 migraine attacks per month during the last 3 months. This frequency must be confirmed in the headache diary before randomization to treatment.
- •Debut of migraine at least one year prior to inclusion
- •Start of migraine before age 50 years
- •No use of other migraine prophylactics during the study
- •For women of child-bearing potential, use of highly effective contraception.
排除标准
- •Interval headache not distinguishable from migraine;
- •Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month
- •Pregnancy, planning to get pregnant, inability to use contraceptives, lactating
- •Clinical information on or signs of cholestasis or decreased hepatic or renal function. If in doubt, relevant blood tests should be performed
- •High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator
- •Hypersensitivity to candesartan
- •History of angioneurotic oedema
- •Current use of antihypertensive medication
- •Current use of potassium supplements
- •Current use of spironolactone
- •Primary hyperaldosteronism (Conn's syndrome)
- •Significant psychiatric illness
- •Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
- •Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years
- •Previous use of candesartan
- •Requiring detoxification from acute medication (triptans, opioids)
- •Consistently failing to respond to any acute migraine medication
- •Alcohol or illicit drug dependence.
- •Inability to understand study procedures and to comply with them for the entire length of the study
研究组 & 干预措施
Control group
Placebo Comparator
干预措施: Placebo oral tablet (Drug)
Candesartan 8 mg
Experimental
干预措施: Candesartan Oral Tablet 8 mg (Drug)
Candesartan 16 mg
Experimental
干预措施: Candesartan Oral Tablet 16 mg (Drug)
结局指标
主要结局
change in number of migraine days per 4 weeks, from baseline
时间窗: 20 weeks plus final visit 1 week after treatment
participants will fill in a headache diary during 20 weeks treatment
次要结局
未报告次要终点
研究者
研究点 (10)
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