Candesartan vs Propranolol for Migraine Prevention: A Double Blind, Placebo Controlled, Double Dummy, Triple Cross-over Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The number of days per 4 weeks with moderate or severe headache lasting ≥ 4 hours or is treated with the patient's usual headache medication
研究概览
简要总结
The main aim of the present study is to compare candesartan with propranolol for migraine prophylaxis.
详细描述
Candesartan was shown to be effective for migraine prophylaxis in a randomized double blind cross-over study published in 2003. The drug is now widely used for this purpose in many countries, although no confirmatory study has been published. The aims of the present study are: 1) to see if the results in the first candesartan study can be replicated in a new patient population, including patients with chronic migraine, and, 2) to perform a head-to-head comparison of candesartan 16 mg/day with standard treatment with propranolol 160 mg slow release. We also intend to study whether responsiveness to these drugs may be related to heart rate variability and baroreceptor sensitivity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 65 years
- •retrospectively have ≥ 2 migraine attacks per month during the last 3 months
- •during the baseline period have ≥ 2 migraine attacks
- •debut of migraine at least one year prior to inclusion
- •start of migraine before age 50 years.
排除标准
- •interval headache not distinguishable from migraine
- •chronic tension-type headache or other headache occurring on ≥ 15 days/month
- •pregnancy, nursing or inability to use contraceptives
- •heart conduction block on ECG or significant ECG abnormality on inclusion
- •heart rate < 54 after 3 minutes rest
- •previous or present asthma, diabetes; decreased hepatic or renal function
- •hypersensitivity to active substance
- •history of angioneurotic edema
- •significant psychiatric illness
- •use of daily migraine prophylactics less than 4 weeks prior to start of study
- •having tried ≥ 3 prophylactic drugs against migraine during the last 10 years
- •previous use of propranolol or candesartan in adequate doses
- •previous discontinuation of either Atacand or Inderal Retard (or another beta blocker) due to side effects
- •current use of antihypertensive medication
- •require use of rizatriptan (Maxalt) 10 mg tabl.
- •subjects requiring detoxification from acute medication (ergotamines, opioids)
- •patients who consistently fail to respond to any acute migraine medication
- •patients with alcohol or illicit drug dependence
研究组 & 干预措施
1 Candesartan
干预措施: Candesartan (Drug)
2 propranolol
干预措施: propranolol (Drug)
3 Placebo
干预措施: placebo (Drug)
结局指标
主要结局
The number of days per 4 weeks with moderate or severe headache lasting ≥ 4 hours or is treated with the patient's usual headache medication
时间窗: One year
次要结局
- Doses of analgesics(one year)
- Doses of triptans(One year)
- Days with sick leave(one year)
- Number of responders (≥ 50% decrease in migraine days compared with baseline)(one year)
- Number of reported side effects(one year)
- Number of predefined retrospective side effects(one year)
- Days with headache(One year)
- Hours with headache(One year)
- Headache intensity (0-3 scale) on days with headache(one year)