UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061142 |
|---|---|
| Receipt number | R000069956 |
| Scientific Title | Investigation of Odor as a Trigger in Patients with Migraine |
| Date of disclosure of the study information | 2026/04/03 |
| Last modified on | 2026/04/02 22:44:21 |
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Basic information
Public title
Investigation of Odor as a Trigger in Patients with Migraine
Acronym
Investigation of Odor as a Trigger in Patients with Migraine
Scientific Title
Investigation of Odor as a Trigger in Patients with Migraine
Scientific Title:Acronym
Investigation of Odor as a Trigger in Patients with Migraine
Region
| Japan |
Condition
Condition
migraine
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between odors and headaches in patients with migraine.
Basic objectives2
Others
Basic objectives -Others
To assess the occurrence of headache after the intervention.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Headache following intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Study participants will inhale an odorant.
Interventions/Control_2
Study participants will inhale a mild odorant.
Interventions/Control_3
Study participants will inhale an odorless substance. (sham)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with migraine who visit Keio University Hospital or Japanese Red Cross Shizuoka Hospital and have agreed to inhale an odor and respond to questionnaires.
Key exclusion criteria
Patients who are pregnant or suspected of being pregnant.
Patients with severe diseases who are considered unable to participate in the study.
Patients who are judged to be unsuitable for participation in this study, etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsubasa |
| Middle name | |
| Last name | Takizawa |
Organization
Keio University School of Medicine
Division name
Neurology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-5363-3788
tsubasa.takizawa@keio.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Takizawa |
Organization
Keio University School of Medicine
Division name
Neurology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-5363-3788
Homepage URL
tsubasa.takizawa@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.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
| 2026 | Year | 04 | Month | 03 | 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
| 2026 | Year | 04 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 02 | Day |
Last modified on
| 2026 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069956
