China HeadAche DIsorders RegiStry (CHAIRS)

Capital Medical University

Status: Enrolling

Conditions: Tension-Type Headache; New Daily Persistent Headache; Trigeminal Autonomic Cephalalgia; Migraine; Headache Disorders, Primary; Medication Overuse Headache

Treatments: Biological: Eptinezumab; Drug: Yangxue Qingnao Granules (Pills); Behavioral: Episodic Migraine and Chronic Migraine; Biological: Erenumab; Behavioral: Medicine Overuse Headache/New Daily Persistent Headache; Behavioral: Patients with other types of primary headache

Study type: Observational

Funder types: Other

Identifiers

NCT05334927

KY2022-tt02

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10,000 participants in 4 patient groups

Medicine Overuse Headache/New Daily Persistent Headache

Description:

The first 18 months were followed up once a month,then followed up once at the 24th month,follow-up visits were made annually after 24 months

Treatment:

Behavioral: Medicine Overuse Headache/New Daily Persistent Headache

Chronic Migraine

Description:

The patients were followed up at 1, 2, 3, 6, 9, 12, 18 and 24 months,then follow-up visits were made annually

Treatment:

Biological: Erenumab

Behavioral: Episodic Migraine and Chronic Migraine

Drug: Yangxue Qingnao Granules (Pills)

Biological: Eptinezumab

Patients with other types of primary headache

Description:

The patients were followed up at 3, 6, 9months

Treatment:

Behavioral: Patients with other types of primary headache

Episodic migraine

Description:

The patients were followed up at 1, 2, 3, 6, 9, 12, 18 and 24 months,then follow-up visits were made annually.

Treatment:

Biological: Erenumab

Drug: Yangxue Qingnao Granules (Pills)

Biological: Eptinezumab