None listed
Conditions
Interventions
Drug : In the test group, 2.4 g of Mecasin is given twice a day for 3 times a day, and riluzole is administered orally twice a day for 24 weeks. In the placebo group, take placebo twice daily for thre
Sponsors
Wonkwang University, Gwangju Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult men and women aged 20 years or older and under 80 years of age, A person who has been diagnosed with ALS only after an EMG (Electroelectricity), MRI, biopsy, cerebral spinal fluid test, blood test, urine test, genetic test, and comprehensive medical examination at medical and general hospitals, ALSFRS score greater than 20, A person taking 100 milligrams of lychel a day from one month before screening, who can visit a hospital alone or visit a hospital with the help of a guardian, who voluntarily agrees to participate in this clinical trial after hearing the purpose, methods, and effects of the clinical trial
Exclusion criteria
Exclusion criteria: Less than 30% of patients with forced lung capacity,Patients with severe mental illness and difficulty communicating with dementia, Patients with myocardial infarction or angina in electrocardiogram, Patients with heart disease who underwent stenting or vascular bypass, Patients with liver disease such as liver cirrhosis, liver cancer, active hepatitis, or patients whose transaminase level is more than three times the normal upper limit, patients with cholecystitis or bile duct obstruction, patients with renal dysfunction and renal dialysis, Patients with organs such as liver and kidney, Patients with interstitial lung disease on chest X-ray examination, Patients suffering from post-operative complications, Persons with previous history of hypersensitivity to components of the test drug and similar classes, A person diagnosed with motor neuron disease due to hereditary diseases (Caneti's disease, SMA4, etc.) or heavy metal poisoning, Women who have not received consent to the choice of oral contraceptives (contraceptives, hormonal implants, intrauterine devices, condoms, spermicides, etc.) in addition to medically appropriate contraceptive methods, pregnancy, breastfeeding, or pregnancy planning (hysterectomy within 2 years of menopause, , A woman who has not undergone bilateral ovariectomy), or a male patient who does not consent to use the appropriate method of contraception to prevent the partner from becoming pregnant while participating in the trial, In patients with progressive muscular atrophy (PMA) with only primary motor sclerosis (PLS) or lower motor neuron symptoms, A person with a bleeding tendency,A person with a malignant tumor, Patients who were found to have active viral infection (Hbs Ag, HCV (hepatitis C virus) Ab, HIV (human immunodeficiency virus)Ab, CMV(Cytomegalovirus) IgM, EBV(Epstein-barr virus) IgM, HSV (herpes simplex virus)IgM, VDRL(Venereal Disease Research Laboratory ), etc.), Patients judged to be inadequate to participate in clinical trials by other clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The baseline adjusted covariance analysis (ANCOVA) was performed to assess the difference between the test group and the placebo group at 24 weeks after dosing, by evaluating the ALS symptom-improving efficacy of K-ALSFRS-R | — |
Secondary
| Measure | Time frame |
|---|---|
| After taking a single dose of the clinical trial drug, the new adverse reaction and abnormal drug response, and the results of laboratory tests and vital signs | — |
Countries
Korea, Republic of
Contacts
Public Contactyeseong Im
Wonkwang University, Gwangju Medical Center
Outcome results
None listed