UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034492
Receipt number R000039331
Scientific Title The effect of Orexin receptor antagonist Suvorexant on REM sleep behavior disorder using Escitalopram(2)
Date of disclosure of the study information 2018/10/15
Last modified on 2018/10/15 09:31:27

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Basic information

Public title

The effect of Orexin receptor antagonist Suvorexant on REM sleep behavior disorder using Escitalopram(2)

Acronym

The effect of Suvorexant on RBD (2)

Scientific Title

The effect of Orexin receptor antagonist Suvorexant on REM sleep behavior disorder using Escitalopram(2)

Scientific Title:Acronym

The effect of Suvorexant on RBD (2)

Region

Japan


Condition

Condition

REM sleep behavior disorder

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The effect of Orexin receptor antagonist Suvorexant on REM sleep behavior disorder using Escitalopram (2)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The decrease of muscle tone on REM sleep

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Double blind pracebo control study of Suvorexanat. Pracebo conditions are: Under using Escitalopram, 8-day drug-free including the other antidepressant and Clonazepam. Video polysomnography at sleep laboratory will be done using 8-day placebo at the last night.

Interventions/Control_2

Double blind pracebo control study of Suvorexanat. Suvorexant conditions are: Under using Escitalopram, 8-day drug-free including the other antidepressant and Clonazepam. Video polysomnography at sleep laboratory will be done using 8-day Suvorexant at the last night.

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

International Classification of Sleep Disorders - Third Edition (ICSD-3). For a diagnosis of REM sleep behavior disorder

Key exclusion criteria

another sleep disorder, mental disorder, medication, or substance use. Subjects are excluded when %RWA is less than 30 under placebo conditions.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takuro Endo

Organization

Sleep clinic Chofu

Division name

Medical devision

Zip code


Address

2-53-1 Kojima-cho Chofu-shi Tokyo Japan

TEL

0424900700

Email

takuro@sleep-t.com


Public contact

Name of contact person

1st name
Middle name
Last name Takuro Endo

Organization

Sleep clinic Chofu

Division name

Medical devision

Zip code


Address

2-53-1 Kojima-cho Chofu-shi Tokyo Japan

TEL

0424900700

Homepage URL


Email

takuro@sleep-t.com


Sponsor or person

Institute

Sleep clinic Chofu

Institute

Department

Personal name



Funding Source

Organization

Sleep clinic Chofu

Organization

Division

Category of Funding Organization

Self funding

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

2018 Year 10 Month 15 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

Preinitiation

Date of protocol fixation

2018 Year 10 Month 05 Day

Date of IRB


Anticipated trial start date

2018 Year 10 Month 15 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

2018 Year 10 Month 15 Day

Last modified on

2018 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039331


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name