Italian Real-life Multicenter Observational Study on Efficacy, Tolerability, and Safety of Innovative Drugs (Monoclonal Antibodies, Gepants, Ditans, Sumatriptan-naproxen) for Preventive or Acute Migraine Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,641
- 试验地点
- 3
- 主要终点
- effectiveness of innovative drugs as migraine prophylaxis
研究概览
简要总结
Approved by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) starting in 2018, anti-CGRP monoclonal antibodies (anti-CGRP mAbs) represent the first true revolution in the preventive treatment of migraine due to their selectivity and specificity. To date, four anti-CGRP mAbs have been developed for the preventive treatment of migraine: eptinezumab, erenumab, fremanezumab, and galcanezumab.Anti-CGRP mAbs constitute not only the first specific and selective treatment for the prevention of migraine but also the most extensively studied pharmacological category in this field, considering the vast and complex populations examined. The clinical effects of the various mAbs are substantially comparable and are characterized by several fundamental aspects:
- High efficacy in both episodic and chronic migraine, with the presence of super-responders who experience a reduction in the average monthly number of migraine days of >75% (or even 100%) compared to before treatment.
- Efficacy that is independent of the clinical form of migraine - with or without aura - and regardless of whether there is analgesic overuse.
- Efficacy maintained even in the presence of depressive or anxious comorbidities.
- Rapid onset of action (even more pronounced with eptinezumab), with the therapeutic effect appearing within the first week in most cases.
- Excellent tolerability with an absence of class-specific adverse events.
- Outstanding treatment adherence and a very low rate of treatment discontinuation in the long term. It should also be noted that the development of anti-drug antibodies or neutralizing antibodies to anti-CGRP mAbs is rare and does not significantly impact the efficacy or tolerability of treatment. Future clinical practice will need to clarify several additional aspects, such as: 1) whether treatment with anti-CGRP mAbs can modify the course of migraine; 2) the appropriate approach regarding any traditional preventive treatment (whether to continue or discontinue it); 3) the definition of the characteristics of non-responders; 4) the definition of patients with a delayed response to treatment.
Gepants are oral antagonists of the CGRP receptor. Among the four gepants synthesized so far (atogepant, rimegepant, ubrogepant, zavegepant), atogepant and rimegepant are currently available in Italy. Atogepant has proven to be an effective and well-tolerated option for the prevention of episodic and chronic migraines. Rimegepant is effective for both acute treatment and prevention of migraines, with a favorable safety profile and flexible oral administration. Lasmiditan is the first ditan effective for migraine attack and it represents a new therapeutic option for patients with contraindications to triptans, due to the presence of vascular risk factors, or for patients who experience undesirable side effects with these, thus increasing the therapeutic possibilities for the symptomatic treatment of migraine. The combination of sumatriptan 85 mg and naproxen sodium 500 mg is indicated for the acute treatment of migraine attacks in adult patients for whom sumatriptan monotherapy is insufficient.
详细描述
The European Headache Federation has published detailed guidelines on the state of the art regarding evidence of effectiveness in reducing the frequency and intensity of headache episodes, as well as the safety and tolerability of the four monoclonal antibodies under "ideal" experimental conditions, with patients selected based on stringent inclusion and exclusion criteria. This selection limits the direct transferability of the conclusions of these studies to clinical reality. Therefore, this study aims to evaluate, in a clinical practice setting, the real effectiveness in reducing the monthly frequency of migraine days and the tolerability and efficacy of monoclonal antibodies in a real-world evidence context. The study may later include all drugs that become available for this condition, subject to authorization by the competent Italian authority.
The present extension of the I-NEED study aims to integrate the collection and evaluation of real-life data on anti-CGRP monoclonal antibodies for migraine prophylaxis with the study of efficacy, safety, and tolerability-also in a real-world evidence context-of gepants in the prophylaxis of episodic and chronic migraine, and of rimegepant, ditans, and the sumatriptan-naproxen combination in the acute treatment of migraine.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more or equal 18 years;
- •Males and females;
- •Willingness to sign the informed consent;
- •Episodic migraine for the use of drug indicated for migraine attack
- •High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months;
- •Chronic migraine, according to the ICHD-III criteria;
排除标准
- •Other headaches different than migraine;
- •Known intolerance to the eccipients;
- •Vascular disease or Raynaud.
研究组 & 干预措施
individuals affected by migraine
episodic and chronic migraine
干预措施: anti-CGRP monoclonal antibodies (Drug)
individuals affected by migraine
episodic and chronic migraine
干预措施: gepants (Drug)
individuals affected by migraine
episodic and chronic migraine
干预措施: combination of sumatriptan and naproxen (Drug)
individuals affected by migraine
episodic and chronic migraine
干预措施: ditan (Drug)
结局指标
主要结局
effectiveness of innovative drugs as migraine prophylaxis
时间窗: the assessment will be conducted at 48 weeks from treatment initiation
reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
effectiveness of innovative drug as migraine prophylaxis
时间窗: the assessment will be conducted at 12 weeks from treatment initiation
reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
2 hour-pain freedom
时间窗: 2 hours
Percentage of patients reporting complete pain relief within 2 hours after taking the innovative drug for migraine attack
effectiveness of innovative drugs as migraine prophylaxis
时间窗: the assessment will be conducted at 48 weeks from treatment initiation
reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
effectiveness of innovative drug as migraine prophylaxis
时间窗: the assessment will be conducted at 12 weeks from treatment initiation
reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
2 hour-pain freedom
时间窗: 2 hours
Percentage of patients reporting complete pain relief within 2 hours after taking the innovative drug for migraine attack
次要结局
- safety and tolerability of innovative drugs as migraine prophylaxis(the assessment will be conducted at 48 weeks from treatment initiation)
- impact of innovative drugs as migraine prophylaxis on symptomatic medication use and medication overuse headache(the assessment will be conducted at 48 weeks from treatment initiation)
- impact of innovative drugs as migraine prophylaxis on migraine symptoms(the assessment will be conducted at 48 weeks from treatment initiation)
- impact of innovative drugs as migraine prophylaxis on migraine-related disability(the assessment will be conducted at 48 weeks from treatment initiation)
- impact of innovative drugs as migraine prophylaxis on interictal disability(the assessment will be conducted at 48 weeks from treatment initiation)
- impact of innovative drugs as migraine prophylaxis on work-related difficulties due to migraine(the assessment will be conducted at 24 weeks from treatment initiation)
- impact of innovatine drugs as migraine prophylaxis on work-related difficulties due to migraine(the assessment will be conducted at 48 weeks from treatment initiation)
- impact of innovative drugs as migraine prophylaxis on economic resources in migraine(the assessment will be conducted at 48 weeks from treatment initiation)
- patient subjective perception(the assessment will be conducted at 48 weeks from treatment initiation)
- response rates to innovative drugs as migraine prophylaxis(the assessment will be conducted at 48 weeks from treatment initiation)
- 1 hour-pain freedom(1 hour after taking the innovative drug for migraine attack)
- 2 hours-pain relief(2 hours after taking the innovative drug for migraine attack)
- disappearance of Most Bothersone Symptom(2 hours after taking the innovative drug for migraine attack)
- presence or absence of associated symptoms (nausea, vomiting, photophobia, phonophobia)(1-48 hours after taking the innovative drug for migraine attack)
- 24 hour-sustained pain freedom(24 hours after taking the innovative drug for migraine attack)
- 24 hour-sustained pain relief(24 hours after taking the innovative drug for migraine attack)
- headache recurrence(2 hours after taking the innovative drug for migraine attack)
- use of rescue medication(24 hours after taking the innovative drug for migraine attack)
- adverse occurence(0-48 hours after taking the innovative drug for migraine attack)
- impact of innovative drugs as migraine prophylaxis on interictal disability(the assessment will be conducted at 48 weeks from treatment initiation)
- impact of innovative drugs as migraine prophylaxis on work-related difficulties due to migraine(the assessment will be conducted at 24 weeks from treatment initiation)
- impact of innovatine drugs as migraine prophylaxis on work-related difficulties due to migraine(the assessment will be conducted at 48 weeks from treatment initiation)
- impact of innovative drugs as migraine prophylaxis on economic resources in migraine(the assessment will be conducted at 48 weeks from treatment initiation)
- patient subjective perception(the assessment will be conducted at 48 weeks from treatment initiation)
- response rates to innovative drugs as migraine prophylaxis(the assessment will be conducted at 48 weeks from treatment initiation)
- 1 hour-pain freedom(1 hour after taking the innovative drug for migraine attack)
- 2 hours-pain relief(2 hours after taking the innovative drug for migraine attack)
- presence or absence of associated symptoms (nausea, vomiting, photophobia, phonophobia)(1-48 hours after taking the innovative drug for migraine attack)
- 24 hour-sustained pain relief(24 hours after taking the innovative drug for migraine attack)
- headache recurrence(2 hours after taking the innovative drug for migraine attack)
- use of rescue medication(24 hours after taking the innovative drug for migraine attack)
- adverse occurence(0-48 hours after taking the innovative drug for migraine attack)
- safety and tolerability of innovative drugs as migraine prophylaxis(the assessment will be conducted at 48 weeks from treatment initiation)
- impact of innovative drugs as migraine prophylaxis on symptomatic medication use and medication overuse headache(the assessment will be conducted at 48 weeks from treatment initiation)
- impact of innovative drugs as migraine prophylaxis on migraine symptoms(the assessment will be conducted at 48 weeks from treatment initiation)
- impact of innovative drugs as migraine prophylaxis on migraine-related disability(the assessment will be conducted at 48 weeks from treatment initiation)