UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041603 |
|---|---|
| Receipt number | R000047492 |
| Scientific Title | The relationship between cranial autonomic symptoms and central sensitization in migraine patients using validated central sensitization inventory |
| Date of disclosure of the study information | 2020/08/29 |
| Last modified on | 2022/06/18 18:08:31 |
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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
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
daisuke_danno@yahoo.co.jp
Sponsor or person
Institute
Tominaga Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047492
