UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059765 |
|---|---|
| Receipt number | R000068342 |
| Scientific Title | Burden of disease study in migraine patients in Japan |
| Date of disclosure of the study information | 2025/11/13 |
| Last modified on | 2025/11/13 15:23:13 |
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Basic information
Public title
Burden of disease study in migraine patients in Japan
Acronym
BRIDGE-J
Scientific Title
Burden of disease study in migraine patients in Japan
Scientific Title:Acronym
BRIDGE-J
Region
| Japan |
Condition
Condition
Migraine
Classification by specialty
| Medicine in general | Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the disease burden in Japanese migraine patients who present to the medical facility that meets the requirements specified in the Optimal Clinical Use Guidelines (OUG) for the use of anti-Calcitonin Gene-Related Peptide (CGRP) antibodies (OUG facility) or Non-OUG facility
Basic objectives2
Others
Basic objectives -Others
Survey for burden of disease
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of Japanese migraine patients categorized as severe based on Headache Impact Test (HIT-6) (score >=60) by the guideline classification of medical facility (OUG facility or Non-OUG facility)
Key secondary outcomes
The following secondary endpoints will be described by the guideline classification of medical facility (OUG facility or Non-OUG facility):
1.The proportion of Japanese migraine patients categorized as severe based on MIBS-4 (score >=5)
2.The mean HIT-6 score of Japanese migraine patients
3.The mean MIBS-4 score of Japanese migraine patients
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.15 years old or more at survey
2.Japan citizen
3.Physician confirmed diagnosis of migraine based on International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria
4.Patients who have given informed consent for participation in this study
Key exclusion criteria
1.Unable to respond to the questionnaire by oneself
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Konishi |
Organization
AbbVie GK
Division name
Medical Affairs
Zip code
108-0023
Address
3-1-21 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-4577-1111
yuko.konishi@abbvie.com
Public contact
Name of contact person
| 1st name | AbbVie GK Clinical Trial Registration Desk |
| Middle name | |
| Last name |
Organization
AbbVie GK
Division name
NA
Zip code
108-0023
Address
3-1-21 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-4577-1111
Homepage URL
abbvie_jpn_info_clingov@abbvie.com
Sponsor or person
Institute
AbbVie GK
Institute
Department
Personal name
Funding Source
Organization
AbbVie GK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Review Board of Human Rights and Ethics for Clinical Studies Ethics Review Committee
Address
2-2-1, Kyobashi, Chuo-ku, Tokyo, Japan
Tel
03-6665-0572
crb@hurecs.org
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a cross-sectional, paper-based survey.
The physician who routinely oversees migraine patients (for physicians at OUG facilities, they must fulfill the physician criteria of OUG for anti-CGRP monoclonal antibodies) will select eligible patients at their site and explain the study to them. To avoid selection bias, physicians will ask eligible patients who meet the inclusion criteria to participate in a consecutive manner.
Management information
Registered date
| 2025 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068342
