Anti-Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibody Response After Switching in the Treatment of Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- 50% response weeks 8-12
研究概览
简要总结
Monoclonal antibodies targeting calcitonin gene-related peptide (mAb-CGRP) have shown efficacy and effectiveness in the treatment of episodic and chronic migraine, however, not all patients respond to them. Preliminary data suggests that some patients who failed to one of them, may respond to a different anti-CGRP monoclonal antibody.
Observational analytic study with a retrospective cohort design including patients treated with a second mAb-CGRP due to lack of response to the first one.
The aim of this study is to provide Class II evidence about the effectiveness and tolerability of the mAb-CGRP switching in patients with migraine, treated in a real-world setting.
详细描述
Background:
Migraine is the first cause of disability in the most active ages of life. Unlike other diseases, there are effective treatments that can lessen the burden of the disease. Currently, there are different treatments that act at different levels, many of them being non-migraine-specific and associated to poor tolerability. The monoclonal antibodies targeting calcitonin gene-related peptide (mAb-CGRP), or its receptor have shown efficacy in the treatment of episodic and chronic migraine, with a significantly lower rate of side effects. In Spain, the National Health System subsidizes them in patients with high-frequency episodic migraine or chronic migraine with prior failure to at least three preventive drugs.
There is preliminary evidence that suggest that approximately one-third of patients who have not responded to one mAb-CGRP may respond to a different mAb-CGRP, not necessarily with a different mechanism of action. The aim of this study is to provide Class II evidence about the effectiveness and tolerability of the mAb-CGRP switching in patients with migraine, treated in a real-world setting.
Study design:
Observational analytic study with a retrospective cohort design.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age over 18 years old;
- •Confirmed diagnosis of migraine, according to the International Classification of Headche Disorders, 3rd version;
- •Treatment with a mAb-CGRP as per responsible physician criteria in routine clinical practice.
排除标准
- •Unavailability of information prior to the treatment use;
- •Other painful disorders that may interfere in the evaluation of the outcomes.
结局指标
主要结局
50% response weeks 8-12
时间窗: Between weeks 8-12 of treatment, compared to the month prior to the start of treatment
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 50% response
次要结局
- 50% response weeks 32-36(Between weeks 32-36 of treatment, compared to the month prior to the start of treatment)
- 30% response weeks 8-12(Between weeks 8-12 of treatment, compared to the month prior to the start of treatment)
- 30% response weeks 20-24(Between weeks 20-24 of treatment, compared to the month prior to the start of treatment)
- 30% response weeks 32-36(Between weeks 32-36 of treatment, compared to the month prior to the start of treatment)
- Change in days of use of symptomatic medication per month weeks 8-12(Between weeks 8-12 with respect to the month prior to the start of treatment)
- 50% response weeks 20-24(Between weeks 20-24 of treatment, compared to the month prior to the start of treatment)
- Change in headache days per month weeks 8-12(Between weeks 8-12 compared to the month prior to starting treatment)
- Change in migraine days per month weeks 8-12(Between weeks 8-12 compared to the month prior to starting treatment)
- Change in days of use of triptan per month weeks 8-12(Between weeks 8-12 with respect to the month prior to the start of treatment)
- Change in days of use of symptomatic medication per month weeks 20-24(Between weeks 20-24 with respect to the month prior to the start of treatment)
- Change in days of use of triptan per month weeks 20-24(Between weeks 20-24 with respect to the month prior to the start of treatment)
- Change in days of use of symptomatic medication per month weeks 32-36(Between weeks 32-36 with respect to the month prior to the start of treatment)
- Adverse events leading to treatment discontinuation(Through study completion, an average of 1 year)
- Change in headache days per month weeks 20-24(Between weeks 20-24 compared to the month prior to starting treatment)
- Change in headache days per month weeks 44-48(Between weeks 44-48 compared to the month prior to starting treatment)
- Change in days of use of symptomatic medication per month weeks 44-48(Between weeks 44-48 with respect to the month prior to the start of treatment)
- Change in days of use of triptan per month weeks 44-48(Between weeks 44-48 compared to the month prior to starting treatment)
- 50% response weeks 44-48(Between weeks 44-48 of treatment, compared to the month prior to the start of treatment)
- 30% response weeks 44-48(Between weeks 44-48 of treatment, compared to the month prior to the start of treatment)
- 75% response weeks 44-48(Between weeks 44-48 of treatment, compared to the month prior to the start of treatment)
- Change in migraine days per month weeks 44-48(Between weeks 44-48 compared to the month prior to starting treatment)
- 75% response weeks 8-12(Between weeks 8-12 of treatment, compared to the month prior to the start of treatment)
- 75% response weeks 20-24(Between weeks 20-24 of treatment, compared to the month prior to the start of treatment)
- 75% response weeks 32-36(Between weeks 32-36 of treatment, compared to the month prior to the start of treatment)
- Change in migraine days per month weeks 20-24(Between weeks 20-24 compared to the month prior to starting treatment)
- Change in headache days per month weeks 32-36(Between weeks 32-36 compared to the month prior to starting treatment)
- Change in migraine days per month weeks 32-36(Between weeks 32-36 compared to the month prior to starting treatment)
- Change in days of use of triptan per month weeks 32-36(Between weeks 32-36 compared to the month prior to the start of treatment)
- Frequency and type of adverse events(Through study completion, an average of 1 year)
- Predictors of 50% response(Between weeks 8-12, in relation to the month prior to the start of treatment)
研究者
David García Azorín
Headache Unit, Department of Neurology, Principal Investigator
Hospital Clínico Universitario de Valladolid