Randomized Double-blind Controlled Exploratory Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
This is a randomized double-blind controlled exploratory clinical study to evaluate the efficacy and safety of FB1006 in the treatment of amyotrophic lateral sclerosis (ALS) patients.
• World Federation of Neurology modified El Ecorial criteria for diagnosis of patients with laboratory support probable, clinically probable, or definite sporadic and familial amyotrophic lateral sclerosis (ALS)
• Age 18 to 80 years old
• ALS duration no longer than 18 months(from day of onset)
• Patient 's ALSFRS-R total scored ≥27，Each single item is scored at least 2（dyspnoea, orthopnea and respiratory insufficiency ≥3）
• Forced vital capacity (FVC%) no less than 70% of predicted normal for gender, height and age
• According to brain function AI analysis in accordance with depressive EEG characteristics
• Women and men of childbearing potential should use medically acceptable contraception
• Voluntarily participate, and sign an informed consent form