Biological Profiling Subjects With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Delta C during attacks
研究概览
简要总结
There are still no reliable biomarkers for migraine; the diagnosis is based on symptomatology, and the pathogenesis remains largely a mystery. However, the past decade has seen a shift from a trial-and-error treatment strategy to a more biologically driven approach using CGRP-targeted drugs (gepants) and monoclonal antibodies (mAbs). This study aims to profile levels of perivascular and hypothalamic neuropeptides, as well as microRNA (miRNA) and neurotrophins, in individuals with migraine. The study builds on a previous pilot investigation (Neuropeptides during migraine attacks, REK 808581).
详细描述
The aim of the study will be achieved by collecting and analyzing blood, saliva, and tears from 30 individuals with migraine and 30 healthy age-, gender- and socio-occupationally matched controls (T0). All the participants will be recruited among the hospital personnel at Nordland Hospital.
Participants with migraine who experience an attack at work during daytime within a 6-month period will immediately contact study staff and undergo collection of blood, saliva and tear fluid (T1). They will then receive oral dissolving rimegepant (Vydura®), which is an effective and legislated treatment of migraine attacks. Two hours later, treatment response and adverse effects will be assessed and new samples collected (T2). The same procedure will be performed 24 hours later (T3). Samples will be collected, handled and analyzed according to our in-house procedures and stored in the Neurological Biobank until analysis.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed and written consent.
- •Men and women, between 18 and 55 years of age.
- •Master a Scandinavian language at level sufficient to fully understand the written and verbal study information.
- •Migraine, with or without aura, fulfilling the International Classification of Headache Disorders (ICHD) III criteria for episodic migraine at time of inclusion. They must report at least 1 attack per month requiring the use of acute medication.
- •Consent to fill out a headache diary for up to 6 months.
排除标准
- •The subject is unable to differentiate migraine from other concomitant headaches
- •The subject having chronic migraine or other chronic pain conditions
- •The subject has severe psychiatric disorders (including depression), substance abuse, severe somatic disorders, and any medical condition that could alter tear and saliva production.
- •Eye disorders that cause pain, require medication or affect tear production.
- •Subjects using tricyclic antidepressant or CGRP antagonists.
- •Contraindication for gepants.
结局指标
主要结局
Delta C during attacks
时间窗: Changes from baseline (T0) to early migraine attack phase (T1), to 2 hours post-rimegepant treatment to 24 hours post-migraine ictus. The time frame from baseline to the migraine attack cannot exceed 6 months.
The concentration of miRNA, neuropeptides, and neurotrophins in plasma, tear fluid, and saliva during the interictal phase compared to the ictal phase of migraine.
次要结局
- Delta C during the interictal phase(Difference in baseline (T0) concentrations between subjects with migraine and healthy controls. These concentrations are measured at a single timepoint during a year of recruitment.)
- Correlations 1(Correlations between concentrations of measured substances in different tissues will be analyzed at individual time points: at the start (T0), early during a migraine attack (T1), 2 hours after treating the attack (T2), and 24 hours after the migraine.)
- Associations(Correlation, regression, and time-series dependences between concentrations of measured substances at individual timepoints (T0, T1, T2, T3) and self-reported triggers, premonitory symptoms and treatment response.)