Amyotrohic Lateral Sclerosi
Conditions
Interventions
Control group:Intravenous injection of 0.9% Sodium Chloride Injection
Sponsors
Yichang Central People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Clinically confirmed, probable, and probable ALS according to the EI Escorial criteria revised in 1998; (2) The subject must be between 18 and 80 years of age (inclusive) at the time of signing the informed consent; (3) Signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Participated in other clinical studies within 3 months; (2) Pregnant and lactating women; (3) Endotracheal intubation or invasive ventilation; (4) Allergic to any component of edaravone; (5) Alt or AST greater than 2 times normal, (6) Creatinine clearance of & Lt. 50 ml per minute, (7) Disease or injury that interferes with functional assessment or is life-threatening, (8) Any known non-ALS-related amyotrophic lateral sclerosis; (9) Major mental illness, cognitive impairment; (10) A history of irregular drug use in the past; (11) Coagulopathy; (12)The presence of proteinuria at a moderate to high level; (13) Patients with impaired liver and kidney function; (14) Systolic blood pressure below 90mmHg, or diastolic blood pressure below 50 mmHg, with a heart rate of less than 50 beats per minute; (15) Had a history of localized inflammation in the last month; (16) Had a history of chronic systemic inflammation; (17) Was unwilling or unable to participate in and complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IL-8;TNF-a;IL-1ß; | — |
Secondary
| Measure | Time frame |
|---|---|
| ALS Functional Rating Scale, ALS-FRS;Respiratory function;Markers of serum programmed necrosis;Cytokine; | — |
Countries
China
Contacts
Public ContactJun Wei
Yichang Central People's Hospital
Outcome results
None listed