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Research on Headache Diagnosis Performance by Headache Diagnosis Program (HM103-01)

Research on Headache Diagnosis Performance by Headache Diagnosis Program (HM103-01)

408

Adults aged 18 years or older who presented with headache at the initial visit and were diagnosed by headache specialists as having, or being suspected of having, primary headache were included.

This was conducted as a multicenter prospective observational study, in which questionnaire data, medical records, and CRFs were collected to prepare evaluation data.

This was an observational study for evaluation data collection, and no notable occurrence of diseases or similar events was described.

This study was conducted for the collection, retrieval, and preparation of evaluation data, and no primary or secondary endpoints were defined.

Questionnaire data, medical records, and CRFs from patients with primary headache or suspected primary headache were prospectively collected to prepare evaluation data for the performance study. The number of cases collected was as follows. Migraine or medication-overuse headache: 250 cases Tension-type headache: 91 cases Trigeminal autonomic cephalalgias: 15 cases Other primary headaches: 8 cases Non-primary headaches: 33 cases Cases with multiple confirmed diagnoses: 11 cases

Mar. 26, 2026

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1030240662

Kawata Yumi

hedgehog medtech.ink

Tokyo,Bunkyo-ku,kouraku2-3-12,sumitomofudousann.iidabashi-buillding F3.Room1

yumi.kawata@h-medtech.com

Kawata Yumi

Clinical Development

Tokyo,Bunkyo-ku,kouraku2-3-12,sumitomofudousann.iidabashi-buillding F3.Room1

+81-90-7554-8471

yumi.kawata@h-medtech.com

Complete

Dec. 09, 2024

Observational

1) Men and women 18 years of age or older
2)Patients are able to obtain written consent for participation in this study of their own free will using the explanation and consent documents approved by the ethics review committee of each research institution.
3) Patients who come to the hospital for the first time with headache as the main complaint (including referrals from other hospitals).
4) Patient has been diagnosed with primary headache or suspected primary headache (one of the following) by a headache specialist at the initial visit.
Migraine or substance abuse headache (MOH) (ICHD-3 code 1 or 8.2)
Tension-type headache (ICHD-3 code 2)
Trigeminal or autonomic headache (ICHD-3 code 3)
Other primary headache (ICHD-3 code 4)
Other than primary headache (ICHD-3 code other than above)
5) All the information in the medical questionnaire and the medical record are all tied to each other and there are no missing observation items.

1) Is currently participating in an interventional study (including clinical trials) other than this study.
2) The patient has a diagnosis of urgent secondary headache.
3) The patient has unclear or other unreadable entries in the records, including neurological findings, in the medical questionnaire or medical record.
4) Other information deemed inappropriate by the principal investigator as the subject of the information.

Both

Primary headache or suspected primary headache

primary headache

D008881

not applicable

Nov. 15, 2024

none