UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003760 |
|---|---|
| Receipt number | R000004109 |
| Scientific Title | Evaluation of L-carnitine: a double-blind comparison of L-carnitine vs. placebo in narcolepsy with cataplexy patients |
| Date of disclosure of the study information | 2010/06/15 |
| Last modified on | 2011/07/15 09:15:03 |
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Basic information
Public title
Evaluation of L-carnitine: a double-blind comparison of L-carnitine vs. placebo in narcolepsy with cataplexy patients
Acronym
Evaluation of L-carnitine in narcolepsy with cataplexy patients
Scientific Title
Evaluation of L-carnitine: a double-blind comparison of L-carnitine vs. placebo in narcolepsy with cataplexy patients
Scientific Title:Acronym
Evaluation of L-carnitine in narcolepsy with cataplexy patients
Region
| Japan |
Condition
Condition
narcolepsy with cataplexy
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of L-carnitine in patients with narcolepsy with cataplexy using ESS, QOL, BMI, sleep diary and actigraph: a randomized crossover trial, single-blind comparison of L-carnitine (510mg per day) and placebo
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of sleep diary and actigraph from 4 to 8 weeks of each administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
L-carnitine to placebo
Interventions/Control_2
placebo to L-carnitine
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients with narcolepsy with cataplexy
2. at least 15 year-old
3. male and female
4. ambulant patients
5. patients who gave a written informed consent
Key exclusion criteria
1. patients with epilepsia (including past history)
2. patients who take a acenocoumarol
3. patients with hypersensitive to components of L-carnitine and placebo
4. patients who are pregnant or desire pregnancy within this study
5. patients who participate in another clinical trial
6. doctor's judgment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Honda |
Organization
Neuropsychiatric Research Institute
Division name
Yoyogi Sleep Clinic
Zip code
Address
TS building, 1-24-10 Yoyogi, Shibuya, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taku Miyagawa |
Organization
The University of Tokyo
Division name
Department of Human Genetics
Zip code
Address
Medical Building No.1, 7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL
03-5841-3693
Homepage URL
taku@jn2.so-net.ne.jp
Sponsor or person
Institute
Yoyogi Sleep Clinic, Neuropsychiatric Research Institute
Institute
Department
Personal name
Funding Source
Organization
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kowa Life Science Foundation, Mitsubishi Pharma Research Foundation and Grant-in-Aid for Young Scientists (B)
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
| 2010 | Year | 06 | 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
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 15 | Day |
Last modified on
| 2011 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004109
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
