About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Medicine Overuse Headache/New Daily Persistent Headache
BehavioralAt 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
Behaviorallong-term follow-up
Patients with other types of primary headache
BehavioralNo collection Brain imaging、Cognitive function test、Biological sample
Yangxue Qingnao Granules (Pills)
DrugParticipants 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
Biological/VaccineParticipants 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
Biological/VaccineParticipants 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).
Treatment groups
Trial outcomes
Primary outcomes
Headache Days
The number of days of headache is the number of days in which headache occurs.
MRI change
Patients will accept MRI scans will be done at baseline and once per year.
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.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) will be used to assess changes in cognitive functions.
Secondary outcomes
Social and demographic data, medical history
Social and demographic data, medical and medication history will be collected at initial screening.
Use of Rescue Medication
Frequency of Rescue medication will be collected by eDiary.
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.
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).
Sponsors and contacts
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