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临床试验/ACTRN12610000126011
ACTRN12610000126011尚未招募3 期

Efficacy of N alpha Methyl histamine versus propranolol in migraine prophylaxis

Hospital General deZona 1 Intituto Mexicano del Seguro Social0 个研究点目标入组 60 人开始时间: 2010年2月8日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • Inclusion Criteria.—The study will include outpatient male and female patients of any race between the ages of 18 and 65 years who have been diagnosed with migraine not attributable to another cause; with or without aura occurring for at least 15 consecutive days in a month, for 3 months in the absence of medication overuse. Migraine must have at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, and/or aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs). With the following occurring during the attack: nausea and/or vomiting or photophobia and/or phonophobia.

排除标准

  • Exclusion Criteria.—The following criteria are grounds for exclusion: female patients who are pregnant (positive urine pregnancy test) or planning to become pregnant during the study period, are breast feeding, or are of childbearing potential and not practicing a reliable method of birth control; patients with evidence of underlying conditions judged to preclude treatment with either test medication; patients who have previously used study medications for any reason; patients unable to discontinue any prohibited medication(s) including carbonic anhydrase inhibitors (eg, acetazolamide, dichlorphenamide), digoxin, metformin, central nervous system depressants (including alcohol), nonstudy anticonvulsant or antiepileptic medications, agents that might interfere with neuromuscular function (eg, aminoglycoside antibiotics, curare-like agents), or hormonal contraceptives; patients with evidence of recent alcohol/drug abuse or acute medication overuse; patients with diabetes mellitus, liver or kidney disease, recent (within 3 months) sepsis or vascular surgery, history of clinically significant pulmonary disease (eg, chronic obstructive pulmonary disease, asthma) active within the previous 12 months, history of heart attack or stroke, cardiac disorder (eg, any clinically significant dysrhythmia), aortic aneurysm, as well as patients at intermediate or higher risk for cardiac disease defined as having 2 or more major risk factors (cigarette smoking, hypotension).

研究者

发起方
Hospital General deZona 1 Intituto Mexicano del Seguro Social

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