UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006298 |
|---|---|
| Receipt number | R000007358 |
| Scientific Title | Ramelteon(melatonin receptor agonist)for neuromuscular degenerative disease and neuroimmunological disease;examination for safety |
| Date of disclosure of the study information | 2011/09/09 |
| Last modified on | 2011/09/07 01:48:55 |
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Basic information
Public title
Ramelteon(melatonin receptor agonist)for neuromuscular degenerative disease and neuroimmunological disease;examination for safety
Acronym
Ramelteon(melatonin receptor agonist)for neurological disease;examination for safety
Scientific Title
Ramelteon(melatonin receptor agonist)for neuromuscular degenerative disease and neuroimmunological disease;examination for safety
Scientific Title:Acronym
Ramelteon(melatonin receptor agonist)for neurological disease;examination for safety
Region
| Japan |
Condition
Condition
neuromuscular degenerative disease and neuroimmunological disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
examinatio for safety and effective use of Ramelteon
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
No significant difference on ODI3 before and after Ramelteon administration.
Key secondary outcomes
Ramelteon utility should be proven by sleep score.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SPO2 monitoring overnight without Ramelteon.
Interventions/Control_2
SPO2 monitoring overnight with Ramelteon.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosed as neuromuscular disease and
neuroimmunological disease.
Patients who obtained mutual agreement of
participation and agreed for outline of
intervention trial.
Key exclusion criteria
As a rule ,these patients are excluded;
patients whose %VC are 50% or less,patients who has respiratory disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | chiharu kugimoto |
Organization
Yokohama city University Graduate School of Medical Science
Division name
Clinical neurology
Zip code
Address
3-9 fukuura,kanazawa-ku,yokohama
TEL
045-787-2725
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | chiharu kugimoto |
Organization
Yokohama city University
Division name
Department of neurology
Zip code
Address
3-9 fukuura,kanazawa-ku,yokohama
TEL
045-78-2725
Homepage URL
Sponsor or person
Institute
Yokohama city University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
横浜市大病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 09 | 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
| 2011 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 07 | Day |
Last modified on
| 2011 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007358
