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.

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. - 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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016233

Enrollment

Registered

2015-01-20

Start date

2015-01-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polymyositis and dermatomyositis

Interventions

TK-98,2 packages a day/ 3 times a day,28weeks Placebo of TK-98,2 packages a day/ 3 times a day.12weeks

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
changes in mean MMT score at 12-week	—

Countries

Japan

Contacts

Public ContactKayoko Kajiwara

Study Coordinating Office, Department of Rheumatology

jimkyoku@ml.tmd.ac.jp03-5803-5380

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026