China HeadAche DIsorders RegiStry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 61
- 主要终点
- Headache Days
研究概览
简要总结
It is planned to include 10000 patients. In the China HeadAche DIsorders RegiStry CHAIRS）, patients aged over 12 years with primary headache and medication-overuse headache(MOH) were collected. The biomarkers, imaging features, cognition, genetic characteristics, ocial and demographic data, medical data, therapeutics used, and outcome of headache-related diseases were studied, and long-term follow-up was planned.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 years old,Any gender;
- •The first onset age of primary headache was less than 50 years old(Age <65 years at first diagnosis of chronic migraine);
- •patients with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3;
- •Sign the informed consent form.
排除标准
- •According to the ICHD-3 diagnostic criteria, there are still headaches directly related to secondary factors (except drug overuse) at the time of enrollment;
- •Those who cannot be diagnosed as primary headache or primary headache combined with medication overuse headache according to ICHD-3;
- •According to DSM-V diagnostic criteria, patients with severe mental diseases (such as schizophrenia, mental disorders associated with mental retardation, etc.);
- •Patients with severe organic diseases, such as malignant tumors, and the expected survival time is less than 1 year;
- •Pregnant,planning pregnancy or Lactating women;
- •Subjects participating in other clinical trials;
- •Unable to cooperate to complete the follow-up due to geographical or other reasons
研究组 & 干预措施
Chronic Migraine
The patients were followed up at 1, 2, 3, 6, 9, 12, 18 and 24 months,then follow-up visits were made annually
干预措施: Erenumab (Biological)
Medicine Overuse Headache/New Daily Persistent Headache
The first 18 months were followed up once a month,then followed up once at the 24th month,follow-up visits were made annually after 24 months
干预措施: Medicine Overuse Headache/New Daily Persistent Headache (Behavioral)
Chronic Migraine
The patients were followed up at 1, 2, 3, 6, 9, 12, 18 and 24 months,then follow-up visits were made annually
干预措施: Episodic Migraine and Chronic Migraine (Behavioral)
Chronic Migraine
The patients were followed up at 1, 2, 3, 6, 9, 12, 18 and 24 months,then follow-up visits were made annually
干预措施: Yangxue Qingnao Granules (Pills) (Drug)
Patients with other types of primary headache
The patients were followed up at 3, 6, 9months
干预措施: Patients with other types of primary headache (Behavioral)
Episodic migraine
The patients were followed up at 1, 2, 3, 6, 9, 12, 18 and 24 months,then follow-up visits were made annually.
干预措施: Yangxue Qingnao Granules (Pills) (Drug)
Episodic migraine
The patients were followed up at 1, 2, 3, 6, 9, 12, 18 and 24 months,then follow-up visits were made annually.
干预措施: Erenumab (Biological)
Chronic Migraine
The patients were followed up at 1, 2, 3, 6, 9, 12, 18 and 24 months,then follow-up visits were made annually
干预措施: Eptinezumab (Biological)
Episodic migraine
The patients were followed up at 1, 2, 3, 6, 9, 12, 18 and 24 months,then follow-up visits were made annually.
干预措施: Eptinezumab (Biological)
结局指标
主要结局
Headache Days
时间窗: long term: 10 years
The number of days of headache is the number of days in which headache occurs.
MRI change
时间窗: long term: 10 years
Patients will accept MRI scans will be done at baseline and once per year.
Patient Health Questionnaire (PHQ)-9
时间窗: long term: 10 years
The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.
Montreal Cognitive Assessment (MoCA)
时间窗: long term: 10 years
The Montreal Cognitive Assessment (MoCA) will be used to assess changes in cognitive functions.
Migraine Disability Assessment (MIDAS)
时间窗: long term: 10 years
The MIDAS is a 7-item questionnaire designed to quantify headache-related disability over a 3- month period. The MIDAS score is the sum of missed work or school days, days at work or school plus days of household work where productivity was reduced by half or more, missed household work days, and missed non-work activity days due to headaches in the last 3 months.
Genetic analysis of familial headache
时间窗: 1 year
Blood samples will be collected from all participants who consent to participate in the study, for the purposes of genetic analysis of familial headache.
Mini-Mental State Exam (MMSE)
时间窗: long term: 10 years
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used in clinical and research settings to assess cognitive function.
Generalized Anxiety Disorder (GAD-7)
时间窗: long term: 10 years
GAD-7 is a proven, self-administered and concise tool for screening and diagnosing mental health disorders, which has been tested in the field in office practice. The GAD-7 scale score ranges from 0 to 21.
Pain freedom at 2 hours
时间窗: 2 hours post-dose
It refers to the complete resolution of headache symptoms within 2 hours after taking the investigational drug, without the use of any rescue medication, and without recurrence of headache during this period.
次要结局
- EEG(long term: 10 years)
- Moderate / Severe Headache Days(long term: 10 years)
- MEG(long term: 10 years)
- Use of Rescue Medication(long term: 10 years)
- Pain severity(long term: 10 years)
- Headache Impact Test (HIT-6)(long term: 10 years)
- Proteomics(1 year)
- Social and demographic data, medical history(long term: 10 years)
- PET(long term: 10 years)
- Microbiome(1 year)
- Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1)(long term: 10 years)
- Columbia-Suicide Severity Rating Scale(long term: 10 years)
- European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)(long term: 10 years)
- Pittsburgh Sleep Quality Index (PSQI)(long term: 10 years)
- Absence of the most bothersome symptom(2 hours post-dose)
- Patient Global Impression of Change (PGIC) Scale(10 years)
- Fatigue Impact Scale (FIS)(10 years)
研究者
Yonggang.wang
MD
Beijing Tiantan Hospital