KCT0001984尚未招募未知
a phase II double-blind randomized placebo-controlled trial of combined Mecasin and riluzole treatment in patients with amyotrophic lateral sclerosis
Wonkwang University, Gwangju Medical Center0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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.
研究者
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