UMIN-CTR Clinical Trial

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

migraine

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokai University School of Medicine

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東海大学医学部付属病院

Date of disclosure of the study information

2015

Year

11

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

11

Month

17

Day

Last modified on

2015

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022899