UMIN-CTR Clinical Trial

Basic information
Public title	The explanation of a role of the central sensitization in the refractory disease patients with various type of symptoms and an improvement of the patients' care: The relationship between cranial autonomic symptoms and central sensitization in migraine patients using validated central sensitization inventory.
Acronym	The explanation of a role of the central sensitization in the refractory disease patients with various type of symptoms and an improvement of the patients' care: The relationship between cranial autonomic symptoms and central sensitization in migraine patients using validated central sensitization inventory.
Scientific Title	The relationship between cranial autonomic symptoms and central sensitization in migraine patients using validated central sensitization inventory
Scientific Title:Acronym	The relationship between cranial autonomic symptoms and central sensitization in migraine patients using validated central sensitization inventory
Region	Japan

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

Objectives
Narrative objectives1	To investigated the relationship between cranial autonomic symptoms and central sensitization in migraine patients using validated central sensitization inventory
Basic objectives2	Others
Basic objectives -Others	Pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Central sensitization severity level in migraine patients 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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) The patients who fulfill International Headache Classification 3rd Edition(beta) 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 trigeminal autonomic cephalalgias (TACs)
Target sample size	200

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	Ministry of Health, Labor and Welfare, Japan
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	Tominaga Hospital Ethics committee
Address	556-0017, 1-4-48 Minatomachi, Naniwa-ku, Osaka-city, Osaka
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	2020 Year 08 Month 29 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	164
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	Main results already published
Date of protocol fixation	2018 Year 05 Month 09 Day
Date of IRB	2018 Year 05 Month 15 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Central sensitization severity level in migraine patients with cranial autonomic symptoms

Management information
Registered date	2020 Year 08 Month 29 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/icdr_e/ctr_view.cgi?recptno=R000047492