China HeadAche DIsorders RegiStry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorBeijing Tiantan Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Medicine Overuse Headache/New Daily Persistent Headache

    Behavioral

    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

    Behavioral

    long-term follow-up

  • Patients with other types of primary headache

    Behavioral

    No collection Brain imaging、Cognitive function test、Biological sample

  • Yangxue Qingnao Granules (Pills)

    Drug

    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

    Biological/Vaccine

    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

    Biological/Vaccine

    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).

Treatment groups

10,000 Participants
are divided into 4 treatment groups
Group A: Medicine Overuse Headache/New Daily Persistent Headache1 intervention
Group B: Chronic Migraine4 interventions
Group C: Patients with other types of primary headache1 intervention
Group D: Episodic migraine3 interventions

Trial outcomes

Primary outcomes

1

Headache Days

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

Time frame
long term: 10 years
2

MRI change

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

Time frame
long term: 10 years
3

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.

Time frame
1 year
4

Montreal Cognitive Assessment (MoCA)

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

Time frame
long term: 10 years

Secondary outcomes

1

Social and demographic data, medical history

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

Time frame
long term: 10 years
2

Use of Rescue Medication

Frequency of Rescue medication will be collected by eDiary.

Time frame
long term: 10 years
3

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.

Time frame
long term: 10 years
4

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).

Time frame
long term: 10 years

Other outcomes

Sponsors and contacts

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