UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055849 |
|---|---|
| Receipt number | R000063674 |
| Scientific Title | A study on the effect of acupuncture on migraine headaches after discontinuing calcitonin gene-related peptide-related preparations |
| Date of disclosure of the study information | 2024/10/16 |
| Last modified on | 2025/07/29 09:49:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the effect of acupuncture on migraine headaches after discontinuing calcitonin gene-related peptide-related preparations
Acronym
A study on the effect of acupuncture on migraine headaches after discontinuing calcitonin gene-related peptide-related preparations
Scientific Title
A study on the effect of acupuncture on migraine headaches after discontinuing calcitonin gene-related peptide-related preparations
Scientific Title:Acronym
A study on the effect of acupuncture on migraine headaches after discontinuing calcitonin gene-related peptide-related preparations
Region
| Japan |
Condition
Condition
Migraine
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the number of migraine days per month when acupuncture treatment is administered for 16 weeks in migraine patients after discontinuing calcitonin gene-related peptide (CGRP)-related preparations, and to clarify whether acupuncture treatment can be an option for migraine treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in the average number of migraine days per month before and after treatment and observation will be compared between groups.
Key secondary outcomes
Comparison of mean changes in MIBS-4, MIDAS, HIT-6, VAS, and SF-36 before and after treatment and observation in each group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Acupuncture
Interventions/Control_2
Traditional Migraine Treatment
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjects who have been treated with CGRP-related drugs for more than three months
(2) Subjects who have been diagnosed with migraine by a specialist from the Japanese Headache Society
(3) Subjects who are able to visit the hospital as outpatients during the treatment and observation period
(4) Subjects who have received oral and written explanations regarding participation in this study and have given their consent
(5) Subjects who are aged between 18 and 80 at the time of obtaining consent
Key exclusion criteria
(1) Patients suspected of having secondary headaches
(2) Patients who have difficulty receiving acupuncture treatment due to metal allergies, etc.
(3) Patients with significant impairment of major organ function, such as liver function, kidney function, lung function, or hemopoietic and hemostatic functions
(4) Pregnant women or women who may be pregnant
(5) Patients with psychiatric disorders or symptoms that are deemed difficult to understand regarding clinical trials
(6) Patients who are otherwise deemed inappropriate by the physicians who are co-investigators of the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Ibata |
Organization
Saitama Medical University
Division name
Oriental medicine of Internal Medicine
Zip code
350-0495
Address
38 Moroyama Hongo, Moroyama-cho, Iruma-gun, Saitama Prefecture
TEL
049-276-1193
ibata.shintaro@1972.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Ibata |
Organization
Saitama Medical University
Division name
Oriental medicine of Internal Medicine
Zip code
350-0495
Address
38 Moroyama Hongo, Moroyama-cho, Iruma-gun, Saitama Prefecture
TEL
049-276-1193
Homepage URL
ibata.shintaro@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Ibata Shintaro
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB Office, Saitama Medical University Hospital
Address
Saitama Medical University Hospital Clinical Research Center
Tel
049-276-1354
hirb@saitama-med.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
| 2024 | Year | 10 | Month | 16 | 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
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2024 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063674
