China HeadAche DIsorders RegiStry

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Study 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. 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

Primary outcome measure(s)

• Headache Days — long term: 10 years
  The number of days of headache is the number of days in which headache occurs.
• MRI change — long term: 10 years
  Patients will accept MRI scans will be done at baseline and once per year.
• Genetic analysis of familial headache — 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) — long term: 10 years
  The Montreal Cognitive Assessment (MoCA) will be used to assess changes in cognitive functions.
• Mini-Mental State Exam (MMSE) — 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) — 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) — 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 — 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 — 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.

Trial sites (61)

+ 21 more sites — see the full list on the official registry below.

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