Amyotrohic Lateral Sclerosi
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) The subject must be between 18 and 80 years of age (inclusive) at the time of signing the informed consent. (2)Diagnosis of probable, clinically probable ALS, clinically probable laboratory-supported ALS, or clinically definite ALS according to the revised El Escorial World Federation of Neurology criteria. (3)The duration of ALS(The time from the first symptom onset to the screening visit) <= 2 years. (4)The ability to take or receive oral medication. (5) Signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Participated in other clinical studies within 3 months; (2) Endotracheal intubation or invasive ventilation; (3) Pregnant and lactating women; (4) ALT or AST greater than 3 times normal;The total bilirubin was increased by more than 2 times the upper limit of the normal range; (5) Creatinine clearance <50ml/min; (6) Disease or injury that interferes with functional assessment or is life-threatening, (7) Any known non-ALS-related amyotrophic lateral sclerosis; (8) Major mental illness, cognitive impairment; (9) Interstitial lung disease, QT prolongation, and bradycardia; (10) Coagulopathy;Patients with impaired liver and kidney function;The presence of proteinuria at a moderate to high level; (11) Was unwilling or unable to participate in and complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum RIPK1;Serum IL-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine;Urine routine;Stool routine;Blood coagulation function;Liver and kidney function;Vital signs;Self-assessment questionnaire; | — |
Countries
China
Contacts
Yichang Central People's Hospital