UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015256 |
|---|---|
| Receipt number | R000017738 |
| Scientific Title | Effect of L-carnitine on nocturnal sleep |
| Date of disclosure of the study information | 2014/09/26 |
| Last modified on | 2015/04/30 15:39:26 |
* 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
Effect of L-carnitine on nocturnal sleep
Acronym
Effect of L-carnitine on nocturnal sleep
Scientific Title
Effect of L-carnitine on nocturnal sleep
Scientific Title:Acronym
Effect of L-carnitine on nocturnal sleep
Region
| Japan |
Condition
Condition
Hypersomnia
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Validation of the effect of L-carnitine on nocturnal sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sleep stage transition probability
Key secondary outcomes
Other PSG sleep variables, subjective change, metabolic measures in blood
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
oral administration of L-carnitine
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients with nocturnal awakenings, fulfilling the criteria of "Central Disorders of Hypersomnolence" in ICSD-3
Key exclusion criteria
past history of epilepsy
those taking acenocoumarol
those who can not follow the regular visiting and medication
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Honda |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Psychitary and Behavioral Sciences
Zip code
Address
2-1-6, Kamikitazawa, Setagaya, Tokyo
TEL
03-5316-3100
honda-mk@igakuken.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Honda |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Psychitary and Behavioral Sciences
Zip code
Address
2-1-6, Kamikitazawa, Setagaya, Tokyo
TEL
03-5316-3100
Homepage URL
honda-mk@igakuken.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Kakenhi
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Neuropsychiatric Research Institute
Name of secondary funder(s)
Tokyo Metropolitan Institute of Medical Science
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 26 | 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
| 2014 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 25 | Day |
Last modified on
| 2015 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017738
