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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003760
Receipt No. 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

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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
Email

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
Email taku@jn2.so-net.ne.jp

Sponsor
Institute Yoyogi Sleep Clinic, Neuropsychiatric Research Institute
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004109

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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