Parenteral Corticosteroids as Adjuvant Therapy for Migraine Headaches
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 3
- 主要终点
- Persistent Headache Pain Free at 24 Hours
研究概览
简要总结
Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
详细描述
Parenteral Corticosteroids as Adjuvant Therapy for Migraine Headaches:
A. Overview/Aims: Five million Americans present to emergency departments (ED) annually with headaches [1]. The majority of these patients have migraine headaches [2,3]. Parenteral medications of proven benefit for acute migraines include the triptans [4], dopamine-receptor antagonists [5-11], non-steroidals [12], and dihydroergotamine [13]. Although these distinct classes of medication are often effective for the treatment of acute migraines, their use is complicated by treatment failures [4,9,14], recurrence of headache [15,16], and side effects [17], all of which are of concern for patients with migraines [18]. The ideal medication, which would rapidly alleviate migraine pain without any recurrence of pain or side effects, has not yet been identified.
The role of corticosteroids in acute migraines is ill-defined. Although used in patients with intractable migraines, this class of medication is not widely used in typical migraine attacks. However, limited clinical data suggest that corticosteroids decrease the rate of recurrent headaches [19-21] and might decrease the pain of an acute attack [22]. Further research is needed to define the role of corticosteroids in the ED treatment of acute migraine headaches.
Specific Aim: The specific aim of this study is to determine the efficacy of ten milligrams of parenteral dexamethasone as adjuvant therapy for the emergency department treatment of migraine headaches.
Primary Hypothesis: Twenty four hours after medication administration, a greater percentage of migraine subjects who received dexamethasone will have:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine with or without aura; probable migraine without aura
排除标准
- •Secondary headache
- •Allergy, contraindication or intolerance to study medication
研究组 & 干预措施
Dexamethasone
Dexamethasone 10 mg
干预措施: Dexamethasone (Drug)
Placebo
Placebo Dexamethasone, 10 mg
干预措施: Placebo (Other)
结局指标
主要结局
Persistent Headache Pain Free at 24 Hours
时间窗: 24 hours
Achieve headache freedom within two hours in the emergency department and no recurrence of pain within 24 hours of emergency department discharge
次要结局
- Functional Disability at 24 Hours(24 hours)
研究者
Benjamin W. Friedman, MD
Prof. Emergency Medicine
Montefiore Medical Center
