a randomized controlled trial of combined Mecasin and riluzole treatment in patients with amyotrophic lateral sclerosis

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

(1) men and women between the ages of 20 and 80; (2) diagnosis of ALS(Amyotrophic Lateral Sclerosis) based on EMG(Electromyography) findings after comprehensive examinations including EMG(Electromyography), MRI(magnetic resonance imageing), biopsy, CSF(cerebrospinal fluid) tests, blood tests, urine tests, and genetic tests at either a university or general hospital; (3) probable diagnosis of ALS(Amyotrophic Lateral Sclerosis); (4) ALSFRS(Amyotrophic Lateral Sclerosis Functional Rating Scale) score greater than 20; (5) ability to communicate in cases of ALS with frontal lobe dementia; (6) ability to walk in cases of ALS with Parkinson’s disease; (7) treatment with 100 mg riluzole up to 3 months prior to screening; (8) ability to visit the hospital alone or with the assistance of a caregiver; and (9) ability to provide voluntary, written informed consent.

Exclusion Criteria

(1) patients with =30% forced vital capacity; 2) patients with severe mental disorders or dementia with communication difficulties; (3) patients with cardiovascular disease including ischemic heart disease; (4) patients with hepatic diseases such as hepatic cirrhosis, hepatic cancer, and active hepatitis, or AST/ALT(aspartateaminotransferase/alanine aminotransaminase) greater than three times the upper normal limit; (5) patients with cholecystitis or biliary obstruction; (6) patients with renal failure or undergoing renal dialysis; (7) patients who have had liver or kidney transplants; (8) patients with interstitial lung disease as observed on chest x-ray; (9) patients who have experienced post-operative complications; (10) patients with a history of hypersensitivity to any component of the experimental medication or similar class of medication; (11) patients with genetic disorders (Kennedy’s disease, SMA4(Spinal muscular atrophy type IV)) or diagnosis of motor neuron disease due to heavy metal poisoning; (12) patients who have received other experimental medication/procedures within four weeks of participating in this trial; (13) pregnant women, lactating women, and women of childbearing age who plan on becoming pregnant (i.e., no hysterectomy, bilateral tubal ligation, or bilateral oophorectomy within 2 years of menopause) who do not agree to use medically appropriate contraceptives (oral medication, hormone implants, intrauterine devices, condoms, or spermicides) or men who do not agree to use appropriate contraceptives with female partners; (14) patients with PLS(primary lateral sclerosis) experiencing only upper motor neuron symptoms or PMA(progressive muscular atrophy) experiencing only lower motor neuron symptoms; (15) patients with bleeding diathesis; (16) patients with malignant tumors; (17) patients who have undergone mechanical ventilation or tracheostomy and PEG(percutaneous endoscopic gastrostomy); (18) patients with active viral infections (Hbs Ag, HCV(hepatitis C virus) Ab, HIV(human immunodeficiency virus) Ab, CMV(Cytomegalovirus) lgM, EBV(Epstein-Barr Virus) lgM, HSV(Herpes Simplex Virus) lgM, VDRL(Venereal Disease Research Laboratory)); and (19) patients who have been determined inappropriate to participate in clinical trials by a clinical examiner.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Korean version of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised

Secondary Outcome Measures

Name	Time	Method
SF-8, Medical Research Council (MRC) scale for muscle strengt, Visual Analog Scale for Pain (VAS Pain);Hamilton Rating Scale for Depression (HRSD), Fatigue Severity Scale (FSS);Patient Global Impression of Change (PGIC)