Study Results
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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RECRUITING
10000 participants
OBSERVATIONAL
2022-08-29
2032-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
long-term follow-up
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).
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).
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).
Patients with other types of primary headache
The patients were followed up at 3, 6, 9months
Patients with other types of primary headache
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)
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
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
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.
Episodic Migraine and Chronic Migraine
long-term follow-up
Patients with other types of primary headache
No collection Brain imaging、Cognitive function test、Biological sample
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).
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).
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).
Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Yonggang.wang
MD
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 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
Countries
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Central Contacts
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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.
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.
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.
Other Identifiers
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KY2022-tt02
Identifier Type: -
Identifier Source: org_study_id
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