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
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
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
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
