Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (The MAMBO Study) Phase I
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Response to sumatriptan
研究概览
简要总结
The goal of this observational study is to identify differential traits in spontaneous migraine attacks that can help us predict the response to treatment with sumatriptan.
Participants will be asked to register the headache characteristics before and after taking sumatriptan and whether the treatment was effective or not during four migraine attacks.
详细描述
There is still an unmet need in acute migraine treatment, some patients don't respond properly to acute medication.
There are some interindividual differences in clinical characteristics of migraine attacks. These differences may determine the response to acute treatment. Describing the phenotypical differences between patients who are responders and patients non-responders will allow us to offer a personalized treatment.
The aim of the study is to determine which characteristics are associated with a response or a non-response to acute treatment with sumatriptan.
Participants will be asked to register the headache characteristics and accompanying symptoms during 4 spontaneous migraine attacks and its response to treatment with sumatriptan.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine with or without aura diagnosis according to ICHD-3 criteria
- •<8 migraine days per month
- •Be able to read, write and understand instructions.
- •Have internet access and mail address
- •Signing of the informed consent
排除标准
- •Active preventive treatment for migraine
- •Active medication with an effect over the central nervous system
- •Serious physical or psychiatric condition
- •Cardiovascular or hepatic disease
- •Pregnant or breastfeeding women
- •Any triptan contraindication
- •Severe migraine attacks without previous response to triptans or NSAIDs
研究组 & 干预措施
episodic migraine
Patients with episodic migraine will be asked to treat four spontaneous migraine attacks with sumatriptan 50 milligrams. They will register the headache characteristics and whether or not the treatment was effective.
干预措施: Sumatriptan (Drug)
结局指标
主要结局
Response to sumatriptan
时间窗: 24 hours
Relief of pain from moderate-severe to mild or absent at 2 hours and 24 hours in 3 out of 4 migraine attacks. The response will be evaluated via questionnaire.
次要结局
- Migraine characteristics(24 hours)