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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000033016
Receipt No. R000037017
Scientific Title Open label, efficacy and safety study of long-term 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) administration to Duchenne muscular dystrophy
Date of disclosure of the study information 2018/08/01
Last modified on 2018/12/14

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Basic information
Public title Open label, efficacy and safety study of long-term 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) administration to Duchenne muscular dystrophy
Acronym Long-term 6-MSITC administration to Duchenne muscular dystrophy
Scientific Title Open label, efficacy and safety study of long-term 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) administration to Duchenne muscular dystrophy
Scientific Title:Acronym Long-term 6-MSITC administration to Duchenne muscular dystrophy
Region
Japan

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

Objectives
Narrative objectives1 Efficacy of 6-MSITC
Basic objectives2 Safety
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, Urinary 8OhDG
Serum AST,ALT,BUN and Cr
WBC,Hb,Plt
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
9mg/day for 8 weeks
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

Not applicable
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 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Awano
Organization Kobe University Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address 7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
TEL +81-78-382-6090
Email awahiro@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Awano
Organization Kobe University Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address 7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
TEL +81-78-382-6090
Homepage URL
Email awahiro@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Productive Aging Laboratory,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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 01 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 Terminated
Date of protocol fixation
2018 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 15 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037017

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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