Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
- 试验地点
- 20
- 主要终点
- Biomarkers of positive initial response to monoclonal antibodies
研究概览
简要总结
Being able to predict each patients response to a specific treatment can mean a significant improvement in socioeconomic costs, but above all in their quality of life. With the present study, the investigators aim to analyze in a combined way different clinical, biological and neuroimaging variables, which allow the clinical staff to anticipate the response to treatment with anti-CGRP monoclonal antibodies in patients with migraine.
详细描述
The study consists of an initial visit coinciding with the start of treatment, a subsequent visit after 6 months of treatment and finally another after 12 months, coinciding with the end of treatment. In case of worsening after suspension, a clinical visit will be carried out at the time of worsening to evaluate the reintroduction of the drug and in case of reintroduction, a visit will be carried out after 3 months. If patients do not worsen, a visit will be made 6 months after completing treatment.
At each visit, demographic and clinical variables will be collected. In addition, 3 blood tests will be performed corresponding to the beginning of treatment, after 6 months and a month and a half from the last infiltration. Likewise, a brain MRI will be obtained prior to the start of treatment. These blood samples and neuroimaging data will be processed for subsequent analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years.
- •Caucasian ethnicity.
- •Patients diagnosed with migraine with and without high-frequency episodic aura (more than 8 days of migraine per month) or chronic by a neurologist expert in headaches and according to the criteria proposed in the International Classification of Headache Diseases, 3rd edition (ICHD- 3).
- •Have at least one year of history of migraine.
- •Patients must maintain stable preventive treatment in the previous month and not have received botulinum toxin in the month prior to starting the monoclonal antibody.
- •Patients able to describe their clinical situation and the characteristics of their headache.
- •Grant your informed consent.
排除标准
- •Patients who present with another type of non-migraine headache, with the exception of headache due to excessive use of analgesic medication.
- •Neurological focus in the examination.
- •Pregnancy or breastfeeding period.
- •Patients with cognitive deficiency or pathology that may prevent or hinder the correct completion of the study.
- •Patients who require changes in preventive treatment during the first 6 months after starting treatment with monoclonal antibodies.
- •Patients who present any significant adverse effect that requires withdrawal or change of anti-CGRP drug.
研究组 & 干预措施
Patients with migraine under treatment with monoclonal antibodies against CGRP
Patients with diagnosis of episodic or chronic migraine who, under the criteria of their neurologist and according to the clinical practice guidelines and standard of care, receive treatment with monoclonal antibodies against CGRP (Galcanezumab, Fremanezumab, Eptinezumab) or else its receptor (Erenumab) will be included.
干预措施: Headache record (Other)
Patients with migraine under treatment with monoclonal antibodies against CGRP
Patients with diagnosis of episodic or chronic migraine who, under the criteria of their neurologist and according to the clinical practice guidelines and standard of care, receive treatment with monoclonal antibodies against CGRP (Galcanezumab, Fremanezumab, Eptinezumab) or else its receptor (Erenumab) will be included.
干预措施: Scales (Other)
Patients with migraine under treatment with monoclonal antibodies against CGRP
Patients with diagnosis of episodic or chronic migraine who, under the criteria of their neurologist and according to the clinical practice guidelines and standard of care, receive treatment with monoclonal antibodies against CGRP (Galcanezumab, Fremanezumab, Eptinezumab) or else its receptor (Erenumab) will be included.
干预措施: Monoclonal antibody anti-CGRP (Drug)
结局指标
主要结局
Biomarkers of positive initial response to monoclonal antibodies
时间窗: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Establish clinical, demographic, transcriptomic, genetic, molecular and/or radiological characteristics that allow predicting a positive initial response to monoclonal antibodies (biomarkers of therapeutic response).
次要结局
- Non-maintained pharmacological response relation with biomarkers(From the beginning of treatment, which is the initial visit, to 18 months of follow-up)
- Sustained response factors(From the beginning of treatment, which is the initial visit, to 18 months of follow-up)
- Sustained response after discontinuation of the anti-CGRP antibody(From the beginning of treatment, which is the initial visit, to 18 months of follow-up)
- Biomarkers of patients with high-frequency episodic migraine and chronic migraine(From the beginning of treatment, which is the initial visit, to 18 months of follow-up)
- Time until relapse after discontinuation of the anti-CGRP antibody(From the beginning of treatment, which is the initial visit, to 18 months of follow-up)
研究者
Ana Gago
Head of the Headache Unit
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa