NCT05536050招募中不适用
Prospective Observational Pilot Study of Low-dose Naltrexone in Patients With Chronic Migraine With Comorbid Fibromyalgia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effectiveness on migraine
研究概览
简要总结
This research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. A few studies suggest low-dose naltrexone is effective for fibromyalgia, but it has not been studied in patients with migraine and headaches. Our goal is to see if there is an improvement in either severity and frequency of attacks and overall impact on quality of life over a three-month period.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be adults of all genders ages 18 and older.
- •Patients with a diagnosis of CM (with or without NDPH) by IHC-3 criteria, diagnosed by a certified headache specialist.
- •Subjects who received a new prescription for LDN
- •Fibromyalgia-diagnosed according to Fibromyalgia Rapid Screening Tool
- •Subjects should be on stable headache and migraine preventives for the past 2 months with no plans to change medication for the next 4 months.
- •Subjects willing to maintain a headache/migraine diary one month prior to taking medication and while taking the medication, either physical or electronic diary of their choice.
- •Subjects willing to fill out pre and post intervention surveys
- •Subjects willing to comply with planned follow up phone calls and visits.
排除标准
- •Not planning on follow up care with clinician.
- •Patients with decreased decision-making capacity in which the investigator's opinion would interfere with the person's ability to provide informed consent and complete study questionnaires.
结局指标
主要结局
Effectiveness on migraine
时间窗: 9-12 weeks
Monthly migraine days
次要结局
- Intensity(9-12 weeks)
- The Migraine Disability Assessment Test(9-12 weeks)
- Patient Health Questionnaire(9-12 weeks)
- Migraine Specific Quality of Life Index(9-12 weeks)
- Fibromyalgia Impact Questionnaire(9-12 weeks)
- Effectiveness on headache(9-12 weeks)
- Patients' Global Impression of Change(9-12 weeks)
研究者
研究点 (1)
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