UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042358
Receipt number R000048356
Scientific Title Investigation on primary headache disorders
Date of disclosure of the study information 2020/11/06
Last modified on 2020/11/05 18:14:36

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Basic information

Public title

Investigation on primary headache disorders

Acronym

Investigation on primary headache disorders

Scientific Title

Investigation on primary headache disorders

Scientific Title:Acronym

Investigation on primary headache disorders

Region

Japan


Condition

Condition

Headache

Classification by specialty

Medicine in general Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Analyzing symptoms/condition, data and treatment on primary headache patients

Basic objectives2

Others

Basic objectives -Others

Epidemiological

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Severity and disability of primary headache disorders etc.

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 diagnosed with primary headache (migraine, tension type headache, cluster headache etc)

Key exclusion criteria

Patients who did not consent

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Tsubasa
Middle name
Last name Takizawa

Organization

Keio University School of Medicine

Division name

Department of Neurology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

0353633788

Email

tsubasa.takizawa@z5.keio.jp


Public contact

Name of contact person

1st name Tsubasa
Middle name
Last name Takizawa

Organization

Keio University School of Medicine

Division name

Department of Neurology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

0353633788

Homepage URL


Email

tsubasa.takizawa@z5.keio.jp


Sponsor or person

Institute

Department of Neurology, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

0333531211

Email

med-rinri-jimu@adst.keio.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

2020 Year 11 Month 06 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

2018 Year 07 Month 23 Day

Date of IRB

2018 Year 07 Month 23 Day

Anticipated trial start date

2018 Year 07 Month 23 Day

Last follow-up date

2024 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is an observational study.


Management information

Registered date

2020 Year 11 Month 05 Day

Last modified on

2020 Year 11 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048356


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name