UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048360 |
|---|---|
| Receipt number | R000055118 |
| Scientific Title | The effects of CGRP pathway monoclonal antibody treatment on inner ear function in patients with migraine: a prospective study |
| Date of disclosure of the study information | 2022/07/13 |
| Last modified on | 2023/04/24 11:39:34 |
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Basic information
Public title
The effects of CGRP pathway monoclonal antibody treatment on inner ear function in patients with migraine: a prospective study
Acronym
The effects of CGRP pathway monoclonal antibody treatment on inner ear function in patients with migraine: a prospective study
Scientific Title
The effects of CGRP pathway monoclonal antibody treatment on inner ear function in patients with migraine: a prospective study
Scientific Title:Acronym
The effects of CGRP pathway monoclonal antibody treatment on inner ear function in patients with migraine: a prospective study
Region
| Japan |
Condition
Condition
migraine
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of CGRP pathway monoclonal antibody treatment on inner ear function in patients with migraine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement of inner ear function after 6-months treatment with CGRP pathway monoclonal antibody
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The migraine patients who needed inner ear function tests
Vestibular migraine patients are eligible
Key exclusion criteria
Treatment duration is less than 3 months
The patients with migraine with brainstem aura
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | TAKESHIMA |
Organization
Tominaga Hospital
Division name
Headache center, Department of neurology
Zip code
556-0017
Address
1-4-48 Minatomachi, Naniwa-ku, Osaka-city, Osaka, Japan
TEL
06-6568-1601
ttakeshi@tominaga.or.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | DANNO |
Organization
Tominaga Hospital
Division name
Headache center, Department of neurology
Zip code
5560017
Address
1-4-48 Minatomachi, Naniwa-ku, Osaka-city, Osaka, Japan
TEL
06-6568-1601
Homepage URL
daisuke_danno@yahoo.co.jp
Sponsor or person
Institute
Tominaga Hospital
Institute
Department
Personal name
Funding Source
Organization
Nil
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
Tominaga Hospital Ethics committee
Address
556-0017 4-48, Minatomachi 1-chome, Naniwa-ku Osaka-city, Osaka
Tel
06-6568-1601
imura@tominaga.or.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 | 07 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nil
Management information
Registered date
| 2022 | Year | 07 | Month | 13 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055118
