amyotrophic lateral sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) The patient or the patients legal representative have provided singed written informed consent; (2) Diagnosis of "probable" or "definite" amyotrophic lateral sclerosis according to the revised El Escorial revised criteria; (3) Ages 20 to 75 years inclusive; (4) First ALS symptoms occurred <=3 monthss prior to screening; (5) Not taking riluzole for at least 3 month prior to the screening visit.
Exclusion criteria
Exclusion criteria: (1) Patients whose EMG examination reveals motor nerve conduction block or sensory nerve conduction abnormalities; (2) Patients in whom causes of neuromuscular weakness other than ALS; (3) Patients who are diagnosed as having dementia or mental disorders; (4) Patients who have serious diseases including cardiovascular, liver, kidney or other serious disease; (5) Onset of the weakness of respiratory muscle.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALSFRS-R; | — |
Secondary
| Measure | Time frame |
|---|---|
| survival rate;MUNE;Muscle strength;Pulmonary function testing;Clinical overall impression score; | — |
Countries
China