UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027333 |
|---|---|
| Receipt number | R000031320 |
| Scientific Title | The effect of Orexin receptor antagonist Suvorexant on REM sleep behavior disorder |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2021/06/03 13:30:38 |
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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
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
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
Sleep clinic IRB
Address
2-53-1 Kojima-cho Chofu-shi Tokyo Japan
Tel
0424900700
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031320
