Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 720
- 试验地点
- 29
- 主要终点
- Frequency of Moderate to Severe Headache Days
研究概览
简要总结
There are two commonly used treatment strategies for treating patients who have chronic migraine with medication overuse. This study will compare the outcomes amongst patients randomized to one of the two treatment strategies.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, at least 21 years of age
- •Chronic Migraine - diagnosed according to ICHD3beta criteria
- •Medication Overuse - diagnosed according to ICHD3beta criteria
- •Willingness to be randomized to either of the two treatment arms
- •Willingness to maintain a headache diary
- •Plan for follow-up care with the clinician
- •No changes to migraine prophylactic therapy within the 4 weeks prior to randomization.
排除标准
- •Younger than 21 years of age
- •Headache diagnoses other than chronic migraine with medication overuse; episodic tension-type headache on 3 or fewer days per month is allowed
- •Not willing to be randomized to either of the treatment arms
- •Not willing to maintain a daily headache diary
- •Not planning on follow-up care with the clinician
- •In the opinion of the clinician, randomization to either treatment arm would be considered unsafe (ex: pregnancy, immediate discontinuation
- •Prisoners
- •Diminished decision-making capacity which in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures.
研究组 & 干预措施
Discontinuation
Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)
干预措施: Discontinuation of Overused Medication (Other)
Preventive Therapy Only
Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)
干预措施: Migraine Prophylactic Therapy Only (Other)
结局指标
主要结局
Frequency of Moderate to Severe Headache Days
时间窗: 12 weeks
Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity
次要结局
未报告次要终点