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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019822
Receipt No. R000022899
Scientific Title The effect of Suvorexant for migraine attack suppression
Date of disclosure of the study information 2015/11/17
Last modified on 2015/11/30

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Basic information
Public title The effect of Suvorexant for migraine attack suppression
Acronym The effect of Suvorexant for migraine attack suppression
Scientific Title The effect of Suvorexant for migraine attack suppression
Scientific Title:Acronym The effect of Suvorexant for migraine attack suppression
Region
Japan

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

Objectives
Narrative objectives1 It's often insomnia in a headache patient. It's often clinical daily and moreover it's experienced to make them deteriorate. Inhibiting effect of a one headache attack as well as improvement of insomnia is considered by improving the degree of the sleep disorder in a one headache patient and throwing the orexin receptor rival medicine which is an insomnia curative (suvorexant) newly this time.
Orexin has deep something to do with a one headache attack, and that orexin falls more than a healthy person in blood and cerebrospinal fluid of a one headache patient (Hamada, Clinical Neurology, 2010).
Suvorexant (orexin antagonist) is thrown in one headache patient all instances with insomnia and the number of times of the headache attack and the degree of serious illness before and after prescription are compared and examined this time.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The evaluation items
* The degree of sleepless serious illness by the suvorexant internal use (Athens score and ISI - J) and the one degree of headache serious illness value (HIT-6 and MIDAS)
Evaluation schedule
* The degree of sleepless serious illness before suvorexant internal use (Athens score and ISI - J) and the one degree of headache serious illness value (HIT-6 and MIDAS)
* The degree of sleepless serious illness for the 1st week after suvorexant internal use (Athens score and ISI - J) and the one degree of headache serious illness value (HIT-6 and MIDAS)
* 1 month later of suvorexant internal use, the degree of sleepless serious illness (Athens score and ISI - J) and the one degree of headache serious illness value (HIT-6 and MIDAS)
* 3 months later of suvorexant internal use, the degree of sleepless serious illness (Athens score and ISI - J) and the one degree of headache serious illness value (HIT-6 and MIDAS)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We prescribe suvorexant to migraine patient with innsomnia
About 80 cases are made a target in 5 years (until March 30, 2020) in this research period of the execution.
The prescription amount conforms to suvorexant package insert by the pharmaceutical company for 3 months in a prescription observation period, and less than 65 years old make 20mg/day and more than 65 years old 15mg/day. The once prescription before sleepness/ day
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

Not applicable
Gender Male and Female
Key inclusion criteria migraineurs with insomnia are diagnized by ICHD-IIIbeta and ICSD-2
Key exclusion criteria Less than 19 years old
Patients who have got serious adverse events by suvorexant

CYP3A inhibitors
Narcolepsy, Catalepsy
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichiro Nagata
Organization Tokai University School of Medicine
Division name Neurology
Zip code
Address 143 Shimo-Kasuya, Isehara, Kanagawa 259-1193, Japan
TEL 0463-93-1121
Email enagata@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiichiro Nagata
Organization Tokai University School of Medicine
Division name Neurology
Zip code
Address 143 Shimo-Kasuya, Isehara, Kanagawa 259-1193, Japan
TEL 0463-93-1121
Homepage URL
Email enagata@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 東海大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 17 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 Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 17 Day
Last modified on
2015 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022899

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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