Novel Diagnostic and Treatment Response Biomarkers in Tear Fluid of Migraine Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Differences in tear biomarker
研究概览
简要总结
The goal of this observational monocentric study is to investigate tear and serum biomarkers in patients with migraine compared with healthy controls, and to explore their potential diagnostic, clinical, and predictive value. In addition to the cross-sectional evaluation, a longitudinal subgroup analysis will be conducted to assess biomarker changes over time during treatment with anti- Calcitonin Gene-Related Peptide (anti-CGRP) therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •patients with migraine
- •Male or female participants aged ≥ 18 years;
- •Diagnosis of migraine according to International Classification of Headache Disorders (ICHD) criteria;
- •Clinical indication, according to routine practice, for treatment with anti-CGRP monoclonal antibodies or gepants (only for the longitudinal subgroup);
- •Ability and willingness to provide written informed consent. Inclusion criteria for healthy controls
- •Male or female participants aged ≥ 18 years;
- •Subjects, without migraine;
- •Ability and willingness to provide written informed consent.
排除标准
- •(for both patients with migraine and healthy controls)
- •Fulfillment of ICHD diagnostic criteria for secondary headaches;
- •Active inflammatory ocular diseases;
- •Severe abnormalities in tear production;
- •Systemic inflammatory diseases that may interfere with biomarker interpretation.
研究组 & 干预措施
Patients with migraine
Patients with migraine
干预措施: Patients with migraine (Diagnostic Test)
Healthy controls
Healthy controls
结局指标
主要结局
Differences in tear biomarker
时间窗: Through the study completion, about 3 years
Differences in tear levels between patients with migraine and healthy controls of the following biomarkers: Calcitonin Gene-Related Peptide (CGRP), pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), Interleukin 10 (IL-10), Interleukin 1β (IL-1β), Tumor necrosis factor-α (TNF-α).
次要结局
- Correlations between tear biomarkers and clinical features of migraine(Through the study completion, about 3 years)
研究者
Vollono Catello
Neurologist
Fondazione Policlinico Universitario Agostino Gemelli IRCCS