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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026016
Receipt No. R000029905
Scientific Title Measuring HMGB1 and soluble forms of Toll-like Receptors in patients with migraine, tension-type headache, and stroke
Date of disclosure of the study information 2017/02/24
Last modified on 2019/01/07

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Basic information
Public title Measuring HMGB1 and soluble forms of Toll-like Receptors in patients with migraine, tension-type headache, and stroke
Acronym HMGB1 and soluble Toll-like Receptors in Migraine, tension-type headache, and stroke
Scientific Title Measuring HMGB1 and soluble forms of Toll-like Receptors in patients with migraine, tension-type headache, and stroke
Scientific Title:Acronym HMGB1 and soluble Toll-like Receptors in Migraine, tension-type headache, and stroke
Region
Japan

Condition
Condition migraine, tension-type headache, stroke
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the dynamics of serum HMGB1 and soluble forms of Toll-like Receptors in patients affected by migraine, tension-type headache, and stroke.

To assess the utility of serum HMGB1 and soluble forms of Toll-like Receptors as disease biomarkers.
Basic objectives2 Others
Basic objectives -Others Chronic headache disorders, such as migraine and tension-type headache, and stroke are among the most common neurological disorders. We previously demonstratated that cortical spreading depression, which is closely related to pathophysiological mechanism of migraine and stroke, causes HMGB1 recelase from cortical neurons and that released HMGB1 acts on Toll-like Receptors on miclogia. In the present study, we aim to assess the utility of serum HMGB1 and soluble forms of Toll-like Receptors as disease biomarkers.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes serum HMGB1 level
serum soluble forms of Toll-like Receptors
Key secondary outcomes Correlations between the above concentrations and disease severity

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
15 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. Those from whom informed consent is obtained
2. Those who are at least 15 years of age
3. Those who satisfy the diagnostic criteria of migraine or tension-type headache
4. Those who are diagnosed with stroke by radiological examinations, such as MRI and CT
Key exclusion criteria 1. Those who do not agree to join the study
2. Those who are considered as ineligible by the attending physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mamoru Shibata
Organization Keio University School of Medicine
Division name Depatment of Neurology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3788
Email mshibata@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mamoru Shibata
Organization Keio University School of Medicine
Division name Department of Neurology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3788
Homepage URL
Email mshibata@a7.keio.jp

Sponsor
Institute Department of Neurology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 02 Month 24 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
2017 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2019 Year 01 Month 07 Day
Date of closure to data entry
2019 Year 01 Month 07 Day
Date trial data considered complete
2019 Year 01 Month 07 Day
Date analysis concluded
2019 Year 01 Month 07 Day

Other
Other related information Nothing

Management information
Registered date
2017 Year 02 Month 06 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029905

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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