UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027825
Receipt No. R000027834
Scientific Title Open label, safty study of 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) to Duchenne muscular dystrophy
Date of disclosure of the study information 2017/06/19
Last modified on 2018/05/31

* 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 Open label, safty study of 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) to Duchenne muscular dystrophy
Acronym Open label study of 6MSITC to DMD
Scientific Title Open label, safty study of 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) to Duchenne muscular dystrophy
Scientific Title:Acronym Open label study of 6MSITC to DMD
Region
Japan

Condition
Condition Duchenne muscular dystrophy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safty of 6-MSITC
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Urinary titin concentration
Key secondary outcomes Serum CK level
Serum AST,ALT,BUN and Cr
WBC,Hb,Pltand PT-INR
Urine examination, Urinary NAG, Urinary beta2MG and Urinary Protein to Cr ratio.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 6-methylsulfinylhexyl Isothiocyanate; 6-MSITC
Oral administraion, 3 times a day
3mg/day for 4 weeks
Washout period for 4 weeks
9mg/day for 4weeks
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
13 years-old <=
Age-upper limit
50 years-old >=
Gender Male
Key inclusion criteria A patient with Duchenne muscular dystrophy confirmed by genetic test and/or immunohistological findings in muscle biopsy
DMD patient who is taking a steroid therapy with consistent dose.
Key exclusion criteria DMD patient who has a severe complication
DMD patient who joined other clinical trials within 6 months
DMD patient who cannot swallow a capsule
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Awano
Organization Kobe Graduate School of medicine
Division name Department of Pediatrics
Zip code
Address 7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-6090
Email awahiro@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Awano
Organization Kobe Graduate School of medicine
Division name Department of Pediatrics
Zip code
Address 7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-6090
Homepage URL
Email awahiro@med.kobe-u.ac.jp

Sponsor
Institute Department of Pediatrics,Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kobe Wellness Science CO.,LTD
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor The Faculty of Rehabilitation, Kobe Gakuin University
Laboratory of Molecular Life Science, Foundation for Biomedical Research and Innovation
Name of secondary funder(s)

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 神戸大学医学部附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 19 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
2016 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2018 Year 01 Month 25 Day
Date analysis concluded
2018 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 06 Month 19 Day
Last modified on
2018 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027834

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.