China HeadAche DIsorders RegiStry

NCT ID: NCT05334927

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-29

Study Completion Date

2032-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Medicine Overuse Headache/New Daily Persistent Headache

Intervention Type BEHAVIORAL

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.

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

Episodic Migraine and Chronic Migraine

Intervention Type BEHAVIORAL

long-term follow-up

Yangxue Qingnao Granules (Pills)

Intervention Type DRUG

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).

Erenumab

Intervention Type BIOLOGICAL

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).

Eptinezumab

Intervention Type BIOLOGICAL

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).

Patients with other types of primary headache

The patients were followed up at 3, 6, 9months

Patients with other types of primary headache

Intervention Type BEHAVIORAL

No collection Brain imaging、Cognitive function test、Biological sample

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.

Yangxue Qingnao Granules (Pills)

Intervention Type DRUG

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).

Erenumab

Intervention Type BIOLOGICAL

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).

Eptinezumab

Intervention Type BIOLOGICAL

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).

Interventions

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Medicine Overuse Headache/New Daily Persistent Headache

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.

Intervention Type BEHAVIORAL

Episodic Migraine and Chronic Migraine

long-term follow-up

Intervention Type BEHAVIORAL

Patients with other types of primary headache

No collection Brain imaging、Cognitive function test、Biological sample

Intervention Type BEHAVIORAL

Yangxue Qingnao Granules (Pills)

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).

Intervention Type DRUG

Erenumab

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).

Intervention Type BIOLOGICAL

Eptinezumab

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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yonggang.wang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Chongqing People's Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

The First Affiliated Hospital of Guangxi University of Chinese Medicine

Nanning, Guangxi, China

Site Status RECRUITING

The First People's Hospital of Zunyi

Zunyi, Guizhou, China

Site Status RECRUITING

Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine

Qionghai, Hainan, China

Site Status RECRUITING

Zhangjiakou First Hospital

Zhangjiakou, Hebei, China

Site Status RECRUITING

Luohe Central Hospital

Luohe, Henan, China

Site Status RECRUITING

Luoyang Central Hospital

Luoyang, Henan, China

Site Status RECRUITING

The Second Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status RECRUITING

The 7th People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Site Status RECRUITING

Changzhou First People's Hospital

Changzhou, Jiangsu, China

Site Status RECRUITING

Jiujiang First People's Hospital

Jiujiang, Jiangxi, China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

Huludao Central Hospital

Huludao, Liaoning, China

Site Status RECRUITING

Zibo Municipal Hospital

Zibo, Shandong, China

Site Status RECRUITING

Dachuan District People's Hospital

Dazhou, Sichuan, China

Site Status RECRUITING

Deyang People's Hospital

Deyang, Sichuan, China

Site Status RECRUITING

The First People's Hospital of Guangyuan

Guangyuan, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yong Gang Wang, Doctor

Role: CONTACT

15010066622 ext. 086

References

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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.

Reference Type DERIVED
PMID: 41091912 (View on PubMed)

Wang 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.

Reference Type DERIVED
PMID: 38516817 (View on PubMed)

Wang 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.

Reference Type DERIVED
PMID: 37098469 (View on PubMed)

Other Identifiers

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KY2022-tt02

Identifier Type: -

Identifier Source: org_study_id

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