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.
- Conditions
- polymyositis and dermatomyositis
- Registration Number
- JPRN-UMIN000016233
- Lead Sponsor
- Tokyo Medical and Dental University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 74
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes in mean MMT score at 12-week
- Secondary Outcome Measures
Name Time Method