UMIN-CTR Clinical Trial

Basic information
Public title	The effect of Orexin receptor antagonist Suvorexant on REM sleep behavior disorder
Acronym	The effect of Suvorexant on RBD
Scientific Title	The effect of Orexin receptor antagonist Suvorexant on REM sleep behavior disorder
Scientific Title:Acronym	The effect of Suvorexant on RBD
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
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 from February 23, 2018. Pracebo conditions are: One week drug-free including antidepressant and Clonazepam. One night polysomnography at sleep laboratory with placebo.
Interventions/Control_2	Double blind pracebo control study of Suvorexanat from February 23, 2018. Suvorexant conditions are: One week drug-free including antidepressant and Clonazepam. One night polysomnography at sleep laboratory with 0.5mg/Kg Suvorexant.
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 Takuro Middle name Last name Endo
Organization	Sleep clinic Chofu
Division name	Medical devision
Zip code	1820026
Address	2-53-1 Kojima-cho Chofu-shi Tokyo Japan
TEL	0424900700
Email	takuroendo@softbank.ne.jp

Public contact
Name of contact person	1st name Takuro Middle name Last name Endo
Organization	Sleep clinic Chofu
Division name	Medical devision
Zip code	1820024
Address	2-53-1 Kojima-cho Chofu-shi Tokyo Japan
TEL	0424900700
Homepage URL
Email	takuro@sleep-t.com

Sponsor
Institute	Sleep clinic Chofu
Institute
Department

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	Sleep clinic IRB
Address	2-53-1 Kojima-cho Chofu-shi Tokyo Japan
Tel	0424900700
Email	takuro@sleep-t.com

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	2017 Year 05 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	2017 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date	2017 Year 05 Month 15 Day
Last follow-up date	2021 Year 06 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 13 Day
Last modified on	2021 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031320