China HeadAche DIsorders RegiStry
CHAIRS
1 other identifier
observational
10,000
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedStudy Start
First participant enrolled
August 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2032
January 15, 2026
December 1, 2025
9.3 years
January 20, 2022
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (9)
Headache Days
The number of days of headache is the number of days in which headache occurs.
long term: 10 years
MRI change
Patients will accept MRI scans will be done at baseline and once per year.
long term: 10 years
Genetic analysis of familial headache
Blood samples will be collected from all participants who consent to participate in the study, for the purposes of genetic analysis of familial headache.
1 year
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) will be used to assess changes in cognitive functions.
long term: 10 years
Mini-Mental State Exam (MMSE)
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used in clinical and research settings to assess cognitive function.
long term: 10 years
Migraine Disability Assessment (MIDAS)
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.
long term: 10 years
Generalized Anxiety Disorder (GAD-7)
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.
long term: 10 years
Patient Health Questionnaire (PHQ)-9
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.
long term: 10 years
Pain freedom at 2 hours
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.
2 hours post-dose
Secondary Outcomes (17)
Social and demographic data, medical history
long term: 10 years
Use of Rescue Medication
long term: 10 years
Moderate / Severe Headache Days
long term: 10 years
Pain severity
long term: 10 years
MEG
long term: 10 years
- +12 more secondary outcomes
Study Arms (4)
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
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
Patients with other types of primary headache
The patients were followed up at 3, 6, 9months
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.
Interventions
No collection Brain imaging、Cognitive function test、Biological sample
Participants who, in routine clinical practice, were prescribed Yangxue Qingnao Granules/Pills for acute headache relief and/or preventive management were enrolled. Treatment initiation, dosing, frequency, and duration were determined by the treating physician and the patient and were not assigned by the study protocol. During the 12-week observation period, participants were followed and outcomes were recorded, including relief of up to four headache episodes (for those using the medication for acute treatment) and longitudinal symptom measures at weeks 4, 8, and 12 (for those receiving preventive management).
Participants who received eptinezumab for migraine prophylaxis in routine clinical practice were included. Treatment decisions (including whether to initiate eptinezumab, the selected dose \[e.g., 100 mg or 300 mg\], infusion interval, and duration) were made by the treating physician in consultation with the patient, and were not assigned by the study protocol. Patients were followed prospectively/retrospectively according to routine clinic visits, with outcome assessments captured at approximately 4-week intervals during the 12-week observation window (and additional follow-up when available).
Participants who received eptinezumab for migraine prophylaxis in routine clinical practice were included. Treatment decisions (including whether to initiate eptinezumab, the selected dose \[e.g., 100 mg or 300 mg\], infusion interval, and duration) were made by the treating physician in consultation with the patient, and were not assigned by the study protocol. Patients were followed prospectively/retrospectively according to routine clinic visits, with outcome assessments captured at approximately 4-week intervals during the 12-week observation window (and additional follow-up when available).
At the end of the 24th month visit, the patient is free to choose whether to conduct a face-to-face visit once a year until death.
Eligibility Criteria
Patients diagnosed with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
Chongqing People's Hospital
Chongqing, Chongqing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, China
The First People's Hospital of Zunyi
Zunyi, Guizhou, China
Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
Qionghai, Hainan, China
Zhangjiakou First Hospital
Zhangjiakou, Hebei, China
Luohe Central Hospital
Luohe, Henan, China
Luoyang Central Hospital
Luoyang, Henan, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
The 7th People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Changzhou First People's Hospital
Changzhou, Jiangsu, China
Jiujiang First People's Hospital
Jiujiang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Huludao Central Hospital
Huludao, Liaoning, China
Zibo Municipal Hospital
Zibo, Shandong, China
Dachuan District People's Hospital
Dazhou, Sichuan, China
Deyang People's Hospital
Deyang, Sichuan, China
The First People's Hospital of Guangyuan
Guangyuan, Sichuan, China
Related Publications (3)
Xiong Z, Qiu D, Liang J, Li X, Guo Z, Zhang M, Liu G, Gao T, Wang Y. Disrupted functional network topology in tension-type headache: A cross-sectional magnetoencephalography study. Cephalalgia. 2025 Oct;45(10):3331024251386425. doi: 10.1177/03331024251386425. Epub 2025 Oct 15.
PMID: 41091912DERIVEDWang W, Qiu D, Mei Y, Bai X, Yuan Z, Zhang X, Xiong Z, Tang H, Zhang P, Zhang Y, Yu X, Wang Z, Ge Z, Sui B, Wang Y. Altered functional connectivity of brainstem nuclei in new daily persistent headache: Evidence from resting-state functional magnetic resonance imaging. CNS Neurosci Ther. 2024 Mar;30(3):e14686. doi: 10.1111/cns.14686.
PMID: 38516817DERIVEDWang W, Yuan Z, Zhang X, Bai X, Tang H, Mei Y, Qiu D, Zhang Y, Zhang P, Zhang X, Zhang Y, Yu X, Sui B, Wang Y. Mapping the aberrant brain functional connectivity in new daily persistent headache: a resting-state functional magnetic resonance imaging study. J Headache Pain. 2023 Apr 26;24(1):46. doi: 10.1186/s10194-023-01577-2.
PMID: 37098469DERIVED
Biospecimen
Whole Blood;serum; Saliva; Feces; Urine; Cerebral Spinal Fluid
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 20, 2022
First Posted
April 19, 2022
Study Start
August 29, 2022
Primary Completion (Estimated)
December 31, 2031
Study Completion (Estimated)
December 31, 2032
Last Updated
January 15, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR