UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061478 |
|---|---|
| Receipt number | R000070331 |
| Scientific Title | Clinical Evaluation of Adherence to Migraine Preventive Medications |
| Date of disclosure of the study information | 2026/05/19 |
| Last modified on | 2026/05/07 17:59:54 |
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Basic information
Public title
Clinical Evaluation of Adherence to Migraine Preventive Medications
Acronym
Clinical Evaluation of Adherence to Migraine Preventive Medications
Scientific Title
Clinical Evaluation of Adherence to Migraine Preventive Medications
Scientific Title:Acronym
Clinical Evaluation of Adherence to Migraine Preventive Medications
Region
| Japan |
Condition
Condition
migraine
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Migraine prevention includes both oral and injectable therapeutic options, with patients typically favoring oral medications. Conventional oral preventive agents have limited immediate efficacy and are often associated with adverse effects, leading to suboptimal adherence. Gepants represent a novel class of oral migraine preventives with demonstrated efficacy and a favorable safety profile, raising expectations for better adherence; nevertheless, empirical data on adherence remain unavailable.
Basic objectives2
Others
Basic objectives -Others
This study is designed to (1) characterize adherence to gepants in clinical practice and compare it with adherence to traditional oral preventive therapies; (2) investigate the relationship between adherence and preventive treatment outcomes; and (3) implement pharmacy-generated tracing reports as an adherence-enhancing strategy and evaluate their impact.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adherance
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients diagnosed with migraine by headache specialists according to the International Classification of Headache Disorders, 3rd edition, who are able to complete a headache diary, will be eligible. Participants must be initiating an oral preventive medication for migraine. There will be no restrictions on age or sex.
Key exclusion criteria
atients considered inappropriate for inclusion based on the clinical judgment of the attending physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba
Division name
Department of Neurosurgery/Headache Clinic
Zip code
3100015
Address
Mito, Ibaraki, 310-0015, Japan
TEL
0292312371
yshibata@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Division name
Department of Neurosurgery/Headache Clinic
Zip code
3100015
Address
Mito, Ibaraki, 310-0015, Japan
TEL
029231-2371
Homepage URL
yshibata@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, Mito Medical Center
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba, Mito Medical Center
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Address
Mito, Ibaraki, 310-0015, Japan
Tel
0292312371
yshibata@md.tsukuba.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 | 05 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For patients whose adherence falls below 60% during the first three months, a pharmacy generated tracing report will be introduced as an intervention, and its impact will be assessed after an additional three month period. The tracing report system is already established in routine clinical practice, whereby pharmacists verify medication intake and remaining pills, provide adherence counseling, and are permitted to submit a monthly insurance claim for this service. The findings are communicated to the attending physician.
Management information
Registered date
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070331
