Headache Disorders, Primary, Medication Overuse Headache, Migraine, New Daily Persistent Headache, Tension-Type Headache, Trigeminal Autonomic Cephalalgia
Conditions
Brief 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.
Interventions
BEHAVIORALMedicine 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.
BEHAVIORALEpisodic Migraine and Chronic Migraine
long-term follow-up
BEHAVIORALPatients with other types of primary headache
No collection Brain imaging、Cognitive function test、Biological sample
DRUGYangxue 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).
BIOLOGICALErenumab
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).
BIOLOGICALEptinezumab
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).
Sponsors
Beijing Tiantan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 12 years old,Any gender; 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
1. According to the ICHD-3 diagnostic criteria, there are still headaches directly related to secondary factors (except drug overuse) at the time of enrollment; 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social and demographic data, medical history | long term: 10 years | Social and demographic data, medical and medication history will be collected at initial screening. |
| Use of Rescue Medication | long term: 10 years | Frequency of Rescue medication will be collected by eDiary. |
| Moderate / Severe Headache Days | long term: 10 years | 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 | long term: 10 years | 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). |
| MEG | long term: 10 years | Patients will accept MEG. |
| PET | long term: 10 years | Patients will accept PET scan. |
| EEG | long term: 10 years | Patients will accept EEG scan. |
| Proteomics | 1 year | 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. |
| Microbiome | 1 year | 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. |
| Headache Impact Test (HIT-6) | long term: 10 years | 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. |
| European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) | long term: 10 years | 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). |
| Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) | long term: 10 years | 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. |
| Pittsburgh Sleep Quality Index (PSQI) | long term: 10 years | The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. |
| Columbia-Suicide Severity Rating Scale | long term: 10 years | 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. |
| Absence of the most bothersome symptom | 2 hours post-dose | 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. |
| Patient Global Impression of Change (PGIC) Scale | 10 years | 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) | 10 years | 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). |
Countries
China
Contacts
CONTACTYong Gang Wang, Doctor
Outcome results
None listed