amyotrophic lateral sclerosis (ALS)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. ALS patients who have been treated at the Xiling Campus of Yichang Central People's Hospital from April 2021 to the present. 2. Age >= 18 year; 3. Diagnosis meets the criteria for clinically definite, clinically probable, or clinically possible ALS according to the 1998 revised El Escorial criteria; or meets the Gold Coast diagnostic criteria for ALS; 4. Treatment with primidone (62.5-125 mg/day); 5. Signed informed consent for off-label use of the drug.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Creatinine clearance < 50 mL/min; 3. Diseases or injuries that interfere with functional assessments or are life-threatening; 4. Any known non-ALS-related motor neuron diseases; 5. Severe psychiatric disorders or cognitive dysfunction; 6. History of localized inflammation or chronic systemic inflammatory diseases prior to medication; 7. History of vision changes, diplopia, nystagmus, ataxia, porphyria, asthma, chronic obstructive pulmonary disease (COPD), or other respiratory diseases that may worsen dyspnea or airway obstruction prior to medication; 8. Presence of major cardiac, renal, hepatic, or other systemic diseases; 9. Unwilling or unable to participate in the study; 10. Missing essential information or inability to obtain eligible biological samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolome; | — |
Secondary
| Measure | Time frame |
|---|---|
| ALSRFS-R Scale Score;CNS-BFS Scale Score ;ROADS Scale Score;Daily Life Function Scale Score;Walking test;Swallowing function;Pulmonary function;RIPK1 levels;RIPK3 levels;MLKL levels;p-RIPK1 levels;p-RIPK3 levels;p-MLKL levels;TNF-a level;IL-8 level; | — |
Countries
China
Contacts
Yichang Central People's Hospital