UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048688 |
|---|---|
| Receipt number | R000055468 |
| Scientific Title | The observational study examining the relationship between climate and the onset of migraine in Japan |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2024/08/22 10:39:16 |
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Basic information
Public title
The observational study examining the relationship between climate and the onset of migraine in Japan
Acronym
Weather study
Scientific Title
The observational study examining the relationship between climate and the onset of migraine in Japan
Scientific Title:Acronym
Weather study
Region
| Japan |
Condition
Condition
Migraine
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
[Primary objective]
The objective of this research study is to "clarify the effect of weather conditions on the onset of migraines" and "whether or not the onset of migraines may increase in a period when the atmospheric pressure changes greatly compared to other seasons" was set as a research question.
[Secondary objective]
- Another objective of this study is to investigate the differences in onset of migraines by region affected by weather changes.
- An analysis of the amount of anti-migraine drugs (triptans) prescribed between seasons will also be performed and a descriptive research study including regionality will be conducted.
Basic objectives2
Others
Basic objectives -Others
[Cross-sectional research study: Case crossover design]
- The amount of triptans prescribed in each season
[Historical cohort research study]
- Date of the first triptan prescription from the index date in the target season
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Cross-sectional research study: Case crossover design]
- The amount of triptans prescribed in each season
[Historical cohort research study]
- Date of the first triptan prescription from the index date in the target season
Key secondary outcomes
[Descriptive research study]
- The amount of triptans prescribed per year and month stratified by region
- Number of patient visits to the medical institution per year and month
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
| 18 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Patients who have been diagnosed with headache based on the following International Classification of Diseases (ICD)-10 codes at least once during the enrollment period
ICD10; G43, G440*, G441*, G442*, G443*, G444*, G448*
* Headaches other than migraine G43 will also be extracted.
Key exclusion criteria
Patients <18 years of age
Patients prescribed a total of 120 tablets of triptans per year
Patients prescribed a total of 120 tablets of ergotamine per year
Patients with comorbidities that may cause secondary headaches
Target sample size
215319
Research contact person
Name of lead principal investigator
| 1st name | Riyo |
| Middle name | |
| Last name | Inuyama |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs Department
Zip code
108-8242
Address
Grand Central Tower 2-16-4 konan,Minato-ku,Tokyo
TEL
03-6717-1400
Inuyama.Lyo@otsuka.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamato |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs Department
Zip code
108-8242
Address
Grand Central Tower 2-16-4 konan,Minato-ku,Tokyo
TEL
03-6717-1400
Homepage URL
Yamato.Kentaro@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The research ethics committee of Otsuka Pharmaceutical Co., Ltd
Address
463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel
088-665-2126
Suzuki.Takashi@otsuka.jp
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
| 2022 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
31440
Results
Regarding the occurrence of migraines (amount of triptan prescribed), it was suggested that the amount of triptan prescribed varies by region and season as cross-sectional study. From the cohort study analysis, no difference was observed in the period from the first day of the season to the prescription of triptan between seasons with high and low atmospheric pressure changes in each region.
Results date posted
| 2024 | Year | 08 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In each year and season, the percentage of patients diagnosed with migraines ranged from 68.4% to 77.8%, with the average age ranging from 44.1 to 44.4 years old. The proportion of females was between 73.6% and 75.6%. The prevalence of comorbidities that could potentially trigger migraines was between 33.1% and 35.7%.
Participant flow
The study targeted patients who met the selection and exclusion criteria based on the health insurance claim data held by JMDC Inc. from January 2017 to December 2021.
Adverse events
NA
Outcome measures
Regarding the occurrence of migraines (amount of triptan prescribed), the amount of triptan prescribed varies by region and season, with the most in Hokkaido in the fall and the least in Shikoku in the spring, suggesting seasonal differences in the occurrence of migraines (amount of triptan prescribed) by region. From the results of the cohort study analysis, no difference was observed in the period from the first day of the season to the prescription of triptan between seasons with many and few atmospheric pressure changes in each region.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 08 | Month | 17 | Day |
Last modified on
| 2024 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055468
