UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034492
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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
URL(English) https://upload.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


Contact us.