EUCTR2019-003386-18-NO招募中1 期
CandMig III studyCandesartan for migraine prevention: A multicentre, binational, triple blind, placebo controlled, parallel group study of two doses of candesartan (8 and 16 mg) - CandMig III
Department of Neurology and Clinical Neurophysiology, St Olavs Hospital, Trondheim University hospital0 个研究点目标入组 450 人开始时间: 2019年10月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 450
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
- •1.Age 18 to 64 years
- •2.Signed informed consent
- •3.Episodic migraine with or without aura according to ICHD-3 criteria(17)
- •4.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 randomisation to treatment .
- •5.Debut of migraine at least one year prior to inclusion
- •6.Start of migraine before age 50 years.
- •7.For women of child-bearing potential (WOCBP, see below) there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception (See below).
- •After the baseline period, just before randomisation to the study drug, inclusion criteria will be evaluated once more, and the headache diary will be evaluated. If there are, according to the headache diary, fewer attacks than 2 or more than 8 per month, the baseline period can be extended to 8 weeks, and the patient can be randomized to a treatment then if there is a mean of 2-8 attacks per 4 weeks during the 8-week’s period.
- •In WOCBP, a pregnancy test in the urine must be performed before start of the treatment period. The women can proceed in the study only if the test is negative.
- •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 450
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Interval headache not distinguishable from migraine;
- •2)2)Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on = 15 days/month
- •3)Pregnancy, planning to get pregnant, nursing or inability to use contraceptives (See inclusion criteria, point 7)
- •4)Clinical information on or signs of cholestasis or decreased hepatic or renal function. If in doubt, relevant blood tests should be performed (See 4.2.3)
- •5)High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization , at the discretion of the investigator
- •6)Hypersensitivity to candesartan
- •7)History of angioneurotic edema
- •8)Current use of antihypertensive medication
- •9)Current use of potassium supplements
- •10)Current use of spironolactone
- •11)Primary hyperaldosteronism (Conn’s syndrome)
- •12)Significant psychiatric illness
- •13)Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
- •14)Having tried = 2 prophylactic drugs against migraine during the last 10 years
- •15)Previous use of candesartan
- •16)Requiring detoxification from acute medication (triptans, opioids)
- •17)Consistently failing to respond to any acute migraine medication
- •18)Alcohol or illicit drug dependence.
- •19)Inability to understand study procedures and to comply with them for the entire length of the study
研究者
相似试验
进行中（未招募）
1 期
CandMig III studyA scientific trial of candesartan in two diffeent doses (8 and 16 mg) as a drug for migraine preventioEUCTR2019-003386-18-EEDepartment of Neurology and Clinical Neurophysiology, St Olavs Hospital, Trondheim University hospital450
已完成
2 期
Candesartan for Migraine Prevention:MigraineNCT04574713St. Olavs Hospital450
已完成
3 期
A clinical trial to study the beneficial effects of drug memantine for the prevention of migraine headacheCTRI/2013/11/004172SRM University60
已完成
3 期
A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.MigraineNCT05810038Pfizer787
已完成
不适用
Adjunctive Treatment of Chronic Migraine Using an Oral Dental DeviceChronic Migraine, HeadacheNCT04871581ChairsideSplint.com25