China Headache Disorders Registry (CHAIRS) for People with Migraine and Other Primary Headaches

China HeadAche DIsorders RegiStry

This project will collect clinical, imaging, biomarker, genetic, and treatment outcome data from people aged 12 and older with primary headache disorders, including migraine and medication‑overuse headache, to see if patterns predict outcomes and guide care.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 20 sites (Beijing, Beijing Municipality and 19 other locations)
• Trial ID: NCT05334927 on ClinicalTrials.gov

What this trial studies

The China HeadAche DIsorders Registry (CHAIRS) aims to enroll up to 10,000 patients aged 12 years and older with primary headache disorders across several tertiary hospitals in China. Participants meeting ICHD‑3 criteria will undergo standardized collection of clinical data, neuroimaging, cognitive testing, blood biomarkers, genetic information, and sociodemographic variables, while treatments and outcomes are recorded. The registry is observational and documents real‑world use of therapies (including traditional preparations and agents such as erenumab) without assigning interventions. Long‑term follow‑up is planned to define disease trajectories, identify predictors of chronification and medication‑overuse headache, and inform personalized care.

Who should consider this trial

Good fit: People aged 12 or older with a primary headache diagnosis (migraine, tension‑type headache, new daily persistent headache, or medication‑overuse headache) according to ICHD‑3 who can provide informed consent are ideal candidates.

Not a fit: Patients whose headaches are due to secondary causes, those with severe mental illness or severe terminal organic disease, and those who are pregnant or planning pregnancy are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the registry could help clinicians match patients to better treatments and identify markers that predict who will develop chronic or medication‑overuse headache.

How similar studies have performed: Large observational headache registries in other countries have successfully described clinical phenotypes and treatment patterns, so the registry approach has precedent though biomarker and genetic discoveries remain ongoing.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 12 years old,Any gender;
2. The first onset age of primary headache was less than 50 years old(Age \<65 years at first diagnosis of chronic migraine);
3. patients with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3;
4. Sign the informed consent form.

Exclusion Criteria:

1. According to the ICHD-3 diagnostic criteria, there are still headaches directly related to secondary factors (except drug overuse) at the time of enrollment;
2. Those who cannot be diagnosed as primary headache or primary headache combined with medication overuse headache according to ICHD-3;
3. According to DSM-V diagnostic criteria, patients with severe mental diseases (such as schizophrenia, mental disorders associated with mental retardation, etc.);
4. Patients with severe organic diseases, such as malignant tumors, and the expected survival time is less than 1 year;
5. Pregnant,planning pregnancy or Lactating women;
6. Subjects participating in other clinical trials;
7. Unable to cooperate to complete the follow-up due to geographical or other reasons

Where this trial is running

Beijing, Beijing Municipality and 19 other locations

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• Beijing Chaoyang Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Chongqing People's Hospital — Chongqing, Chongqing Municipality, China (RECRUITING)
• Fujian Provincial Hospital — Fuzhou, Fujian, China (RECRUITING)
• The First Affiliated Hospital of Guangxi University of Chinese Medicine — Nanning, Guangxi, China (RECRUITING)
• The First People's Hospital of Zunyi — Zunyi, Guizhou, China (RECRUITING)
• Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine — Qionghai, Hainan, China (RECRUITING)
• Zhangjiakou First Hospital — Zhangjiakou, Hebei, China (RECRUITING)
• Luohe Central Hospital — Luohe, Henan, China (RECRUITING)
• Luoyang Central Hospital — Luoyang, Henan, China (RECRUITING)
• The Second Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (RECRUITING)
• The 7th People's Hospital of Zhengzhou — Zhengzhou, Henan, China (RECRUITING)
• Changzhou First People's Hospital — Changzhou, Jiangsu, China (RECRUITING)
• Jiujiang First People's Hospital — Jiujiang, Jiangxi, China (RECRUITING)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)
• Huludao Central Hospital — Huludao, Liaoning, China (RECRUITING)
• Zibo Municipal Hospital — Zibo, Shandong, China (RECRUITING)
• Dachuan District People's Hospital — Dazhou, Sichuan, China (RECRUITING)
• Deyang People's Hospital — Deyang, Sichuan, China (RECRUITING)
• The First People's Hospital of Guangyuan — Guangyuan, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Yong Gang Wang, Doctor

Conditions: Headache Disorders, Primary, Migraine, New Daily Persistent Headache, Medication Overuse Headache, Tension-Type Headache, Trigeminal Autonomic Cephalalgia