Headache Disorders, PrimaryCHAIRSNCT05334927
China HeadAche DIsorders RegiStry
An observational study of Headache Disorders, Primary and Migraine, run by Beijing Tiantan Hospital at 61 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Headache Disorders, Primary, Migraine, New Daily Persistent Headache
- What is being tested?
- Medicine Overuse Headache/New Daily Persistent Headache, Episodic Migraine and Chronic Migraine and Patients with other types of primary headache
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- How many people
- 10,000 participants
- Where
- 61 sitesChina
- Study dates
- 29 Aug 2022to 31 Dec 2032
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
61 sites in 1 country. Contact the study team or a site near you to ask about taking part.
61 sites in 1 country
China61 sites, 61 recruiting
- Recruiting
Anqing Municipal Hospital
Anqing, Anhui
- Recruiting
Ansteel Group General Hospital
Anshan, Liaoning
- Recruiting
Baotou Central Hospital
Baotou, Inner Mongolia
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
- Recruiting
The First Hospital of Fangshan District, Beijing
Beijing, Beijing Municipality
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
- Recruiting
The Second Hospital of Jilin University
Changchun, Jilin
- Recruiting
Changzhou First People's Hospital
Changzhou, Jiangsu
- Recruiting
Chengdu Second People's Hospital
Chengdu, Sichuan
- Recruiting
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan
- Recruiting
Chongqing People's Hospital
Chongqing, Chongqing Municipality
- Recruiting
The Third Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
- Recruiting
Dachuan District People's Hospital
Dazhou, Sichuan
- Recruiting
Deyang People's Hospital
Deyang, Sichuan
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian
- Recruiting
Guangyuan Hospital of Traditional Chinese Medicin
Guangyuan, Sichuan
- Recruiting
The First People's Hospital of Guangyuan
Guangyuan, Sichuan
- Recruiting
The Second People's Hospital of Guiyang
Guiyang, Guizhou
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
- Recruiting
Huludao Central Hospital
Huludao, Liaoning
- Recruiting
Huzhou Central Hospital
Huzhou, Zhejiang
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
- Recruiting
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
- Recruiting
Jiujiang First People's Hospital
Jiujiang, Jiangxi
- Recruiting
The Second Hospital of Lanzhou University
Lanzhou, Gansu
- Recruiting
Luohe Central Hospital
Luohe, Henan
- Recruiting
Luoyang Central Hospital
Luoyang, Henan
- Recruiting
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
- Recruiting
Yiyang County People's Hospital
Luoyang, Henan
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
- Recruiting
Nanchong Central Hospital
Nanchong, Sichuan
- Recruiting
Brain Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu
- Recruiting
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi
- Recruiting
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
- Recruiting
Panzhihua Central Hospital
Panzhihua, Sichuan
- Recruiting
Qinhuangdao Haigang Hospital
Qinhuangdao, Hebei
- Recruiting
Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
Qionghai, Hainan
- Recruiting
Shanghai Jiao Tong University School of Medicine Affiliated Tongren Hospital
Shanghai, Shanghai Municipality
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong
- Recruiting
Siyang Hospital
Siyang, Sichuan
- Recruiting
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
- Recruiting
Xinjiang Production and Construction Corps Hospital
Ürümqi, Xinjiang
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hebei
- Recruiting
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)
Wuhu, Anhui
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
- Recruiting
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian
- Recruiting
Qinghe County People's Hospital
Xingtai, Hebei
- Recruiting
Xuchang Central Hospital
Xuchang, Henan
- Recruiting
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei
- Recruiting
Yangyuan County People's Hospital
Zhangjiakou, Hebei
- Recruiting
Zhangjiakou First Hospital
Zhangjiakou, Hebei
- Recruiting
The 7th People's Hospital of Zhengzhou
Zhengzhou, Henan
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
- Recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan
- Recruiting
Zibo Municipal Hospital
Zibo, Shandong
- Recruiting
Zigong First People's Hospital
Zigong, Sichuan
- Recruiting
The First People's Hospital of Zunyi
Zunyi, Guizhou
About this study
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.
- Conditions
- Headache Disorders, Primary, Migraine, New Daily Persistent Headache, Medication Overuse Headache, Tension-Type Headache, Trigeminal Autonomic Cephalalgia
- Being tested
- Medicine Overuse Headache/New Daily Persistent Headache, Episodic Migraine and Chronic Migraine, Patients with other types of primary headache, Yangxue Qingnao Granules (Pills), Erenumab
- Medical subject headings
- Headache Disorders, Primary, Migraine Disorders, Headache Disorders, Secondary, Tension-Type Headache, Trigeminal Autonomic Cephalalgias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicine Overuse Headache/New Daily Persistent HeadacheBehavioural
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.
Episodic Migraine and Chronic MigraineBehavioural
long-term follow-up
Patients with other types of primary headacheBehavioural
No collection Brain imaging、Cognitive function test、Biological sample
Yangxue Qingnao Granules (Pills)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).
ErenumabBiological
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).
EptinezumabBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Medicine Overuse Headache/New Daily Persistent Headache | |
| 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 Receives: Behavioral: Episodic Migraine and Chronic Migraine; Drug: Yangxue Qingnao Granules (Pills); Biological: Erenumab; Biological: Eptinezumab | |
| Patients with other types of primary headache | The patients were followed up at 3, 6, 9months Receives: Behavioral: Patients with other types of primary headache | |
| 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. Receives: Drug: Yangxue Qingnao Granules (Pills); Biological: Erenumab; Biological: Eptinezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Days
The number of days of headache is the number of days in which headache occurs.
Measured: long term: 10 years
MRI change
Patients will accept MRI scans will be done at baseline and once per year.
Measured: 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.
Measured: 1 year
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) will be used to assess changes in cognitive functions.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 hours post-dose
Secondary outcomes (17)
Social and demographic data, medical history
Social and demographic data, medical and medication history will be collected at initial screening.
Measured: long term: 10 years
Use of Rescue Medication
Frequency of Rescue medication will be collected by eDiary.
Measured: long term: 10 years
Moderate / Severe Headache Days
Moderate / severe headache days are defined as a day in which moderate or severe pain persists for at least 4 hours, or headache lasts for one day after successful medication for acute headache. These definitions allow the use of relatively simple headache diaries. Subjects were required to indicate whether headache was present (yes / no), peak (mild / moderate / severe) severity and duration (< 4h or 4h), type of acute drug intake, and response to treatment should also be recorded.
Measured: long term: 10 years
Pain severity
Pain severity were captured through Visual analogue scale (VAS) for pain, a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).
Measured: long term: 10 years
MEG
Patients will accept MEG.
Measured: long term: 10 years
PET
Patients will accept PET scan.
Measured: long term: 10 years
EEG
Patients will accept EEG scan.
Measured: long term: 10 years
Proteomics
Blood, urine and Cerebrospinal fluid samples will be collected from all participants who consent to participate in the study, for the purposes of Proteomics at baseline and month 12.
Measured: 1 year
Microbiome
Saliva samples will be collected from all participants who consent to participate in the study, for the purposes of Microbiome at baseline and month 12.
Measured: 1 year
Headache Impact Test (HIT-6)
The HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function.
Measured: long term: 10 years
European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
EQ-5D-3L is a generic instrument for use as a measure of health status. The EQ-5D-3L consists of 2 components-the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.
The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labelled "Best imaginable health state" and "Worst imaginable health state." The scoring range of the EQ VAS is from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: long term: 10 years
Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1)
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive assesses how migraines limit one's daily social and work-related activities; Role Function Preventive assesses how migraines prevent these activities; and the Emotional Function domain assesses the emotions associated with migraines.
Measured: long term: 10 years
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep.
Measured: long term: 10 years
Columbia-Suicide Severity Rating Scale
C-SSRS will be administered to study subjects at each study visit to assess possible suicidal ideation and behavior. Reports of suicidal ideation with intent to act (endorse item 4 or 5) and reports of actual, aborted, or interrupted suicide attempts or a behavior preparatory for making an attempt indicate subjects at high risk for suicide.
Measured: long term: 10 years
Absence of the most bothersome symptom
It refers to the complete resolution of the patient's self-identified most bothersome migraine-associated symptom (including photophobia, phonophobia, nausea, etc.) within 2 hours after taking the study medication.
Measured: 2 hours post-dose
Patient Global Impression of Change (PGIC) Scale
The Patient Global Impression of Change (PGIC) Scale is a single-item, patient-reported measure of overall change in symptoms, activity limitation, mood, and overall quality of life since starting treatment at this institution. Scores range from 1 to 7, where 1 = no improvement (or condition worsened) and 7 = very large improvement; higher scores indicate better improvement (better outcome).
Measured: 10 years
Fatigue Impact Scale (FIS)
Fatigue Impact Scale (FIS) is a standardized questionnaire assessing the impact of fatigue on daily functioning (cognitive, physical, and psychosocial domains). Each item is scored 0-4; the total score ranges from 0 to 160 (sum of 40 items). Higher scores indicate greater fatigue impact (worse outcome).
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start29 Aug 2022
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Headache Disorders, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonggang.wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334927
- Sponsor's protocol ID
- KY2022-tt02
- Acronym
- CHAIRS
- Status last verified
- Dec 2025
- First submitted
- 20 Jan 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Li X, Li R, Liu G, Qiu D, Mei Y, Xiong Z, Yuan Z, Zhang P, Zhang M, Liu X, Tang H, Zhang Y, Yu X, Liu Y, Sui B, Wang Y. Iron deposition network mapping of disease occurrence and clinical manifestations in migraine: A prospective study. Cephalalgia. 2026 Jan;46(1):3331024261416488. doi: 10.1177/03331024261416488. Epub 2026 Jan 28.
PubMed 41603449Lin C, Li Y, Wang Z, Duan C, Liu G, Guo Z, Li X, Xiong Z, Chen T, Zhang M, Gao T, Sui B, Wang Y. Abnormal neurovascular coupling in the precuneus associated with migraine chronification: A multimodal magnetic resonance imaging study. Cephalalgia. 2025 Nov;45(11):3331024251396031. doi: 10.1177/03331024251396031. Epub 2025 Nov 12.
PubMed 41223010Xiong 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.
PubMed 41091912Wang 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.
PubMed 38516817Wang 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.
PubMed 37098469
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China HeadAche DIsorders RegiStry
- ClinicalTrials.gov ID
- NCT05334927
- Acronym / sponsor ID
- CHAIRS / KY2022-tt02
- Conditions
- Headache Disorders, Primary, Migraine, New Daily Persistent Headache, Medication Overuse Headache, Tension-Type Headache, Trigeminal Autonomic Cephalalgia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Medicine Overuse Headache/New Daily Persistent Headache | – | Behavioral: Medicine Overuse Headache/New Daily Persistent HeadacheThe 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 | – | Behavioral: Episodic Migraine and Chronic Migraine, Drug: Yangxue Qingnao Granules (Pills), Biological: Erenumab, Biological: EptinezumabThe 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 | – | Behavioral: Patients with other types of primary headacheThe patients were followed up at 3, 6, 9months |
| Episodic migraine | – | Drug: Yangxue Qingnao Granules (Pills), Biological: Erenumab, Biological: EptinezumabThe patients were followed up at 1, 2, 3, 6, 9, 12, 18 and 24 months,then follow-up visits were made annually. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicine Overuse Headache/New Daily Persistent HeadacheAt 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. | Behavioural | Medicine Overuse Headache/New Daily Persistent Headache |
| Episodic Migraine and Chronic Migrainelong-term follow-up | Behavioural | Chronic Migraine |
| Patients with other types of primary headacheNo collection Brain imaging、Cognitive function test、Biological sample | Behavioural | Patients with other types of primary headache |
| 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). | Drug | Chronic Migraine, Episodic migraine |
| ErenumabParticipants 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). | Biological | Chronic Migraine, Episodic migraine |
| EptinezumabParticipants 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). | Biological | Chronic Migraine, Episodic migraine |
Primary outcome
Headache Days
Time frame: long term: 10 years
The number of days of headache is the number of days in which headache occurs.
MRI change
Time frame: long term: 10 years
Patients will accept MRI scans will be done at baseline and once per year.
Genetic analysis of familial headache
Time frame: 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.
Montreal Cognitive Assessment (MoCA)
Time frame: long term: 10 years
The Montreal Cognitive Assessment (MoCA) will be used to assess changes in cognitive functions.
Mini-Mental State Exam (MMSE)
Time frame: 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.
Migraine Disability Assessment (MIDAS)
Time frame: 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.
Generalized Anxiety Disorder (GAD-7)
Time frame: 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.
Patient Health Questionnaire (PHQ)-9
Time frame: 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.
Pain freedom at 2 hours
Time frame: 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.
17 secondary outcomes
Social and demographic data, medical history
Time frame: long term: 10 years
Use of Rescue Medication
Time frame: long term: 10 years
Moderate / Severe Headache Days
Time frame: long term: 10 years
Pain severity
Time frame: long term: 10 years
MEG
Time frame: long term: 10 years
PET
Time frame: long term: 10 years
EEG
Time frame: long term: 10 years
Proteomics
Time frame: 1 year
Microbiome
Time frame: 1 year
Headache Impact Test (HIT-6)
Time frame: long term: 10 years
European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
Time frame: long term: 10 years
Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1)
Time frame: long term: 10 years
Pittsburgh Sleep Quality Index (PSQI)
Time frame: long term: 10 years
Columbia-Suicide Severity Rating Scale
Time frame: long term: 10 years
Absence of the most bothersome symptom
Time frame: 2 hours post-dose
Patient Global Impression of Change (PGIC) Scale
Time frame: 10 years
Fatigue Impact Scale (FIS)
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 41603449Li X, Li R, Liu G, Qiu D, Mei Y, Xiong Z, Yuan Z, Zhang P, Zhang M, Liu X, Tang H, Zhang Y, Yu X, Liu Y, Sui B, Wang Y. Iron deposition network mapping of disease occurrence and clinical manifestations in migraine: A prospective study. Cephalalgia. 2026 Jan;46(1):3331024261416488. doi: 10.1177/03331024261416488. Epub 2026 Jan 28.
- Derived from this study: PubMed 41223010Lin C, Li Y, Wang Z, Duan C, Liu G, Guo Z, Li X, Xiong Z, Chen T, Zhang M, Gao T, Sui B, Wang Y. Abnormal neurovascular coupling in the precuneus associated with migraine chronification: A multimodal magnetic resonance imaging study. Cephalalgia. 2025 Nov;45(11):3331024251396031. doi: 10.1177/03331024251396031. Epub 2025 Nov 12.
- Derived from this study: PubMed 41091912Xiong 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.
- Derived from this study: PubMed 38516817Wang 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.
- Derived from this study: PubMed 37098469Wang 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.
- Individual participant dataSharing planned: Yes
Related trials for Headache Disorders, Primary
RecruitingPhase 2/3
Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
Migraine, With or Without Aura
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
Not yet recruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
RecruitingObservational study
Overlapping Pain Trajectory Study
Migraine, Musculoskeletal Pain
RecruitingObservational study
(Italian Migraine Registry, I-GRAINE-NEW)
Migraine Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache Disorders, Primary and Migraine, run by Beijing Tiantan Hospital at 61 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Gang Wang, Doctor (15010066622 ext. 086, w100yg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Days (time frame: long term: 10 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05334927, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.