Amyotrophic Lateral Sclerosis
Conditions
Interventions
experimental group 1:TBN tablets 600 mg
experimental group 2:TBN tablets 1200 mg
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 45 to 70 years old (inclusive), gender is not limited; 2) Diagnosis in accordance with ALS Revised Criteria of the World Federation of Neurology, 1998, diagnosis of definite or probable ALS. 3) Subjects has a disease duration of 2 points when enroll, and the respiratory function in ALSFRS-R is 4 points; 5) ALSFRS-R score decreases by 1-4 points (inclusive) during the screening period; 6) Forced Vital Capacity (%FVC) >= 80% before randomization; 7) Subjects must understand and be will to compliant with the study rules, voluntarily participate, and sign an informed consent form (informed consent form is voluntarily signed by the subject himself/herself or his/her legal representative).
Exclusion criteria
Exclusion criteria: 1) Patients with familial amyotrophic lateral sclerosis(according to family history) 2) Patients with obvious cognitive impairment (MMSE scale: illiterate group 8 years) 3 times ULN, or other identified liver diseases such as acute and chronic hepatitis, cirrhosis, etc.; 6) From the screening period, in the past 6 months, patients come up with acute myocardial infarction or interventional therapy, heart failure (NYHA CLASS III-IV); 7) Combined with malignant tumors or other systematic diseases such as digestive system disease and hematological system diseases. 8) Patients who are allergic to the investigational product or tetramethylpyrazine; 9) Female patients in pregnancy or lactation; 10) Having participated in other clinical studies within 30 days before randomization, or is participating in other clinical studies; 11) Patients that the investigator considers unsuitable for participation in the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Grip strength;FVC;ALSAQ-40;Time to reach the end event; | — |
Primary
| Measure | Time frame |
|---|---|
| ALSFRS-R; | — |
Countries
China
Contacts
Public ContactDongsheng Fan
Outcome results
None listed