UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033016
Receipt number 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 16:53:13

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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 or person

Institute

Kobe University

Institute

Department

Personal name



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

Value
https://center6.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