China HeadAche DIsorders RegiStry

The number of days of headache is the number of days in which headache occurs.

Patients will accept MRI scans will be done at baseline and once per 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.

The Montreal Cognitive Assessment (MoCA) will be used to assess changes in cognitive functions.

The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used in clinical and research settings to assess cognitive function.

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.

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.

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.

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.

Social and demographic data, medical and medication history will be collected at initial screening.

Frequency of Rescue medication will be collected by eDiary.

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 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).

Patients will accept MEG.

Patients will accept PET scan.

Patients will accept EEG scan.

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.

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.

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.

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).

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.

The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep.

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.

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.

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).

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).