UMIN-CTR Clinical Trial

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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