Amyotrophic Lateral Sclerosis
Conditions
Interventions
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 |
|---|---|
| serum inflammatory factors;programmed necrosis markers;oxidative stress injury markers; | — |
Secondary
| Measure | Time frame |
|---|---|
| ALS Functional Rating Scale, ALS-FRS;Respiratory function; | — |
Countries
China
Contacts
Public ContactJun Wei
Yichang Central People's Hospital
Outcome results
None listed