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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038825
Receipt No. R000044271
Scientific Title Cranial autonomic symptoms in migraine: Prospective observational study
Date of disclosure of the study information 2019/12/09
Last modified on 2019/12/09

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Basic information
Public title Cranial autonomic symptoms in migraine: Prospective observational study
Acronym Cranial autonomic symptoms in migraine: Prospective observational study
Scientific Title Cranial autonomic symptoms in migraine: Prospective observational study
Scientific Title:Acronym Cranial autonomic symptoms in migraine: Prospective observational study
Region
Japan

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

Objectives
Narrative objectives1 To clarify the prevalence of migraine with cranial autonomic symptoms (CAS +) and without (CAS-) in patients presenting at a tertiary headache center in Japan.
Basic objectives2 Others
Basic objectives -Others To investigate the migraine clinical phenotype.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The prevalence of migraine with cranial autonomic symptoms
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 1) The patients who fulfill International Headache Classification 3rd Edition criteria of 1.1 Migraine without Aura, 1.2 migraine with Aura, and 1.3 Chronic migraine.
2) Medication overuse headache is eligible
3) Inpatients or outpatients
4) Patients with written informed consent.
Key exclusion criteria 1) Patients with secondary headache except for medication overuse headache
2) Patients with hemicrania continua and new daily persistent headache.
3) Patients judged by doctors as inappropriate for this study
Target sample size 500

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
Headache center, Department of neurology
Institute
Department

Funding Source
Organization None
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 Institutional Review Board
Address 556-0017 1-4-48 Minatomachi, Naniwa-ku, Osaka-city, Osaka, Japan
Tel 06-6568-1601
Email honda@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
2019 Year 12 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 373
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 Completed
Date of protocol fixation
2016 Year 07 Month 24 Day
Date of IRB
2016 Year 08 Month 09 Day
Anticipated trial start date
2016 Year 08 Month 10 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2019 Year 12 Month 09 Day
Last modified on
2019 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044271

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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