Monoclonal Antibody Duration of REsponse in MIgraine After Treatment Interruption: A Prospective National Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Return to the baseline
研究概览
简要总结
Observational analytic study with a prospective cohort design. Patients with episodic and chronic migraine that have responded to monoclonal antibodies (mAbs) versus calcitonin gene-related peptide (CGRP) or its receptor with positive response will be included. A headache diary will be completed in a daily basis. The primary outcome will be the time elapsed between the discontinuation of the monoclonal antibody and the return to the clinical situation at the moment of the mAbs onset. The potential variables that may be associated with a more sustained benefit will be explored.
详细描述
Introduction:
The development of new preventive treatments represents a new era in the treatment of migraine. Different drugs have shown a reduction in the number of headache days, average intensity of pain and the need for symptomatic treatment in randomized, placebo-controlled trials; nonetheless, there are unanswered questions from clinical trials which are of a particular interest to routine clinical practice.
The duration of preventive treatments is not fully established, in the different clinical trials the duration of treatment ranged between 3, 6 or 12 months 3-12 . Additionally, it is known that the benefit of a preventive drugs may persist once interrupted, while in other cases, patients may return to the previous situation in a relatively short period of time. In the case of other preventive treatments, the therapeutic effect seems to be maintained for a longer period after the discontinuation of the treatment.
Preventive drugs targeting the Calcitonin gene-related peptide (CGRP) or its receptor have been approved. In Spain three of them (erenumab, galcanezumab and fremanezumab) are subsidized for the treatment of episodic migraine or chronic migraine in patients with at least 8 days of migraine per month and who have previously failed at least 3 preventive treatments. Still, the long-term duration of therapeutic effect once these treatments are suspended has not been clarified yet.
As the duration of the effect after discontinuing treatment and the optimal duration of treatment are not fully known, the present study aims to evaluate patients with migraine who have been treated with monoclonal antibodies. Additionally, the needed time to return to the situation prior to this treatment will be studied. The factors that may be associated with the duration of the benefit after the treatment discontinuation will be explored by using survival analysis methods.
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 diagnosed with episodic or chronic migraine according to criteria of the International Classification of Headache Disorders, 3rd Edition.
- •Patients who previously received treatment with a monoclonal antibody (mABs) against CGRP or its receptor at the discretion of their usual neurologist, according to the standard of care and local guidelines.
- •Patients who experienced a positive therapeutic response to mAbs.
- •Patients that received the treatment for a minimum of 3 months.
- •Age between 18 and 65 years.
- •Participants must be capable to describe his/her clinical situation and the characteristics of his/her headache.
- •Participants must have signed the informed consent and have sufficient understanding of Spanish language.
排除标准
- •Presence of another type of concomitant chronic headache, defined by frequency greater than 15 days per month in the previous three months, except for medication overuse headache.
- •Patients planning to start another treatment with a possible preventive effect according to the national clinical practice guidelines within the six following weeks after their inclusion in the present study for any therapeutic indication.
- •Patients who started another treatment with a possible preventive effect according to the national clinical practice guidelines within the previous six weeks of the evaluation of the inclusion in the present study.
- •Pregnancy or breastfeeding.
- •Patients who discontinued treatment with the monoclonal antibody due to an adverse effect and not to an efficacy response.
结局指标
主要结局
Return to the baseline
时间窗: Through study completion, an average of 3 months
The needed number of months elapsed until the patient has a number of headache days per month that equals the situation at the moment of the monoclonal antibody onset, or the need of other prophylactic medication.
次要结局
- Worsening within the first three months(Through study completion, an average of 3 months)
- Worsening between three and six months(Through study completion, an average of 6 months)
- Worsening between six and nine months(Through study completion, an average of 9 months)
- Worsening between nine and twelve months(Through study completion, an average of 12 months)
- Explore predictors of a more prolonged response(Through study completion, an average of 12 months)
研究者
David García Azorín
Headache Unit, Department of Neurology, Principal Investigator
Hospital Clínico Universitario de Valladolid