Amyotrophic lateral sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. ALS patients who visited the Xiling Campus of Yichang Central People's Hospital from April 2021 to the present; 2. Age >= 18 years; 3. Diagnosis met the criteria for clinically definite, clinically probable, or clinically possible ALS according to the revised El Escorial criteria (1998), or fulfilled the Gold Coast diagnostic criteria for ALS; 4. Underwent treatment with primidone (62.5-125 mg/day); 5. Provided signed informed consent for off-label drug use.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Creatinine clearance < 50 mL/min; 3. Any disease or injury that would interfere with functional assessments or be life-threatening; 4. Any known non-ALS related motor neuron disease; 5. Significant psychiatric illness or cognitive impairment; 6. History of localized inflammation or chronic systemic inflammatory disease prior to medication; 7. Pre-existing visual changes, diplopia, nystagmus, ataxia, porphyria, asthma, chronic obstructive pulmonary disease (COPD), or other respiratory conditions that may exacerbate dyspnea or airway obstruction; 8. Significant cardiac, renal, hepatic, or other systemic diseases; 9. Unwilling or unable to participate in the study; 10. Lack of essential data or inability to obtain qualified biological samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALSRFS-R Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| ROADS Scale Score;CNS-BFS Scale Score ;Daily Life Function Scale Score;Walking test;Blood RIPK1 levels;Blood RIPK3 levels;Blood MLKL levels;Blood p-RIPK1 levels;Blood p-RIPK3 levels;Blood p-MLKL levels;Swallowing function;Pulmonary function; | — |
Countries
China
Contacts
Yichang Central People's Hospital