UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056264
Receipt number R000064281
Scientific Title A study of clinical characteristics of hemiplegic migraine
Date of disclosure of the study information 2024/11/25
Last modified on 2024/11/25 13:13:27

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Basic information

Public title

A study of clinical characteristics of hemiplegic migraine

Acronym

A study of clinical characteristics of hemiplegic migraine

Scientific Title

A study of clinical characteristics of hemiplegic migraine

Scientific Title:Acronym

A study of clinical characteristics of hemiplegic migraine

Region

Japan


Condition

Condition

Hemiplegic migraine

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To clarify the clinical characteristics of hemiplegic migraine in Japan

Basic objectives2

Others

Basic objectives -Others

To clarify the clinical characteristics of hemiplegic migraine in Japan

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

NA

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

Patients with hemiplegic migraine (ICHD-3 1.2.3)

Key exclusion criteria

Patients with secondary headache

Target sample size

80


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 or person

Institute

NA

Institute

Department

Personal name



Funding Source

Organization

NA

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, 1-4-48 Minatomachi, 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

2024 Year 11 Month 25 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

80

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

2024 Year 11 Month 06 Day

Anticipated trial start date

2024 Year 11 Month 07 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

NA


Management information

Registered date

2024 Year 11 Month 25 Day

Last modified on

2024 Year 11 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064281