UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016233
Receipt number R000018837
Scientific Title A Phase II/III, randomized, double-blind, placebo-controlled study and open active-treatment extension study to assess the efficacy and safety of the branch chain amino acids (BCAAs) in polymyositis and dDermatomyositis.
Date of disclosure of the study information 2015/01/20
Last modified on 2020/07/08 11:43:41

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Basic information

Public title

A Phase II/III, randomized, double-blind, placebo-controlled study and open active-treatment extension study to assess the efficacy and safety of the branch chain amino acids (BCAAs) in polymyositis and dDermatomyositis.

Acronym

A Phase II/III, randomized, double-blind, placebo-controlled study and open active-treatment extension study to assess the efficacy and safety of the branch chain amino acids (BCAAs) in polymyositis and dermatomyositis.

Scientific Title

A Phase II/III, randomized, double-blind, placebo-controlled study and open active-treatment extension study to assess the efficacy and safety of the branch chain amino acids (BCAAs) in polymyositis and dDermatomyositis.

Scientific Title:Acronym

A Phase II/III, randomized, double-blind, placebo-controlled study and open active-treatment extension study to assess the efficacy and safety of the branch chain amino acids (BCAAs) in polymyositis and dermatomyositis.

Region

Japan


Condition

Condition

polymyositis and dermatomyositis

Classification by specialty

Endocrinology and Metabolism Neurology Clinical immunology
Dermatology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To show the superiority of TK-98 (branch chain amino acids) compared to placebo using changes in mean MMT score at 12-week as a primary endpoint for efficacy of improvement of muscle weakness by a randomized, double-blind, placebo-controlled study, the subjects with polymyositis (PM) and dermatomyositis (DM) who will be treated with corticosteroids as an initial treatment, will take TK-98 for 12 -weeks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II,III


Assessment

Primary outcomes

changes in mean MMT score at 12-week

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

TK-98,2 packages a day/
3 times a day,28weeks

Interventions/Control_2

Placebo of TK-98,2 packages a day/
3 times a day.12weeks

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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients who have been diagnosed as probable or definite cases, based on Bohan and Peter's criteria.
2) Patients who will be treated for PM/DM for the first time.
3) Serum creatine kinase level or serum aldolase level exceed the reference value
4) Mean MMT score is 6 to 9.5 bilateral muscle of deltoid,biceps,triceps, brachioradialis, iliopsoas,gluteus maximus,quadriceps femoris,and hamstring and neck flexor muscle,neck extensor muscle
5) Patients who will be treated with more than 0.75mg per kg per day or 60mg per body per day of prednisolone or equivalent dose of other glucocorticoids.
6) Age20 to75 years old.
7) Patients who require hospitalization.
8) Patients who are able and willing to provide written informed consent.

Key exclusion criteria

1) Patients will be excluded from the study if they were subject to any of the following treatment:
i) previously received LIVACT granules and its generic drug
ii) amino acid supplement, enteral nutrient, amino acid solution, TPN, and PPN within the last 1 week
iii) anti-TNF-alpha, etanercept, abatacept, tocilizumab, ustekinumab, rituximab, eculizumab within the last 6 weeks
iv) gamma-globulin within the last 6 weeks
v) plasmapheresis within the last 6 weeks.
2) Patients with other muscular disorders (muscular dystrophy and IBM etc).
3) Patients with paralytic symptoms.
4) Patients with malignant tumors.
5) Patients with severe interstitial pneumonia.
6) Patients with hypothyroidism.
7) Patients with severe renal disorders (serum creatinine level 2.0mg/dL).
8) Patients with severe cardiac diseases and/or severe hepatic disorders.
9) Patients with congenital aminoacidopathy.
10) Patients with dysphagia who have difficulty in swallowing.
11) Patients who have the past history of shock/hypersensitivity to BCAA or corticosteroids.
12) Patients with the past or a complication of drug addiction or alcoholism.
13) Pregnant, or lactating patients, and female patients of reproductive potential who are unwilling to use a highly effective method of contraception.
14) Past and/or current use of other investigational therapy within 6 months.
15) Any other patients who not eligible to the study according to the investigators.

Target sample size

74


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitoshi Kohsaka

Organization

Tokyo Medical and Dental University

Division name

Department of Rheumatology

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-2231

Email

kohsaka.rheu@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kayoko Kajiwara

Organization

Study Coordinating Office,

Division name

Department of Rheumatology

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5380

Homepage URL


Email

jimkyoku@ml.tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

2015 Year 01 Month 20 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

2014 Year 11 Month 27 Day

Date of IRB

2014 Year 12 Month 26 Day

Anticipated trial start date

2015 Year 01 Month 20 Day

Last follow-up date

2018 Year 08 Month 31 Day

Date of closure to data entry

2018 Year 09 Month 30 Day

Date trial data considered complete

2018 Year 11 Month 30 Day

Date analysis concluded

2019 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2015 Year 01 Month 16 Day

Last modified on

2020 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018837


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name