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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048097
Receipt No. R000054819
Scientific Title Treatment of hemiplegic migraine with Anti-CGRP monoclonal antibodies: a retrospective study
Date of disclosure of the study information 2022/06/18
Last modified on 2022/06/18

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Basic information
Public title Treatment of hemiplegic migraine with Anti-CGRP monoclonal antibodies: a retrospective study
Acronym Treatment of hemiplegic migraine with Anti-CGRP monoclonal antibodies: a retrospective study
Scientific Title Treatment of hemiplegic migraine with Anti-CGRP monoclonal antibodies: a retrospective study
Scientific Title:Acronym Treatment of hemiplegic migraine with Anti-CGRP monoclonal antibodies: a retrospective study
Region
Japan

Condition
Condition Hemiplegic migraine
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the therapeutic effect of hemiplegic migraine with CGRP-related antibodies
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes from baseline in monthly headache days
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

Not applicable
Gender Male and Female
Key inclusion criteria Hemiplegic migraine cases treated with CGRP-related antibodies
Key exclusion criteria Treatment duration is less than 3 months
No motor symptoms at baseline
Target sample size 6

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
Email 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 556-0017
Address 1-4-48 Minatomachi, Naniwa-ku, Osaka-city, Osaka, Japan
TEL 06-6568-1601
Homepage URL
Email daisuke_danno@yahoo.co.jp

Sponsor
Institute Tominaga Hospital
Institute
Department

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
Email 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 06 Month 18 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 Enrolling by invitation
Date of protocol fixation
2022 Year 03 Month 31 Day
Date of IRB
2022 Year 06 Month 08 Day
Anticipated trial start date
2022 Year 03 Month 31 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information An observational study

Management information
Registered date
2022 Year 06 Month 18 Day
Last modified on
2022 Year 06 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054819

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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