Amyotrophic lateral sclerosis
Conditions
Interventions
Treatment group:TP04HN106
Control group:placebo
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) (2020 Gold Coast criteria, see Appendix 1 for details); 2. Age>= 18 years old, male or female; 3. The Amyotrophic Lateral Sclerosis Function Rating Scale (ALSFRS-R, see Appendix 2 for details) of the subjects before the screening visit should be >= 1 point for dyspnea, orthopnea, and respiratory insufficiency; 4. Before randomization, subjects received stable doses of riluzole tablets for >= 7 days, and should keep the treatment drug until the last study visit; 5. Voluntarily participate in clinical trials, sign informed consent, and understand and comply with research procedures.
Exclusion criteria
Exclusion criteria: 1. The subject is known to be allergic to the experimental drug or the excipients contained therein; 2. The subject suffers from diseases or injuries that interfere with functional assessment or endanger life, or is accompanied by severe irreversible diseases of the heart, lung, liver, or brain, or is accompanied by different organ failure (for patients with respiratory failure, only patients diagnosed with type I or type II respiratory failure are excluded); 3. The subject suffers from major mental illness and cognitive dysfunction; 4. Patients with a history of secondary surgery or above within one month before the screening period; 5. The subject has participated in other clinical studies within 1 month; 6. The subjects were pregnant and lactating women; 7. Those who have poor compliance or have any conditions that the investigator thinks are not suitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALSFRS-R score at the end of the 10th week; | — |
Secondary
| Measure | Time frame |
|---|---|
| ALSFRS-R score at the end of the 2nd, 6th, 12th, 14th, 18th, 22nd, and 28th weeks;Rasch score at the end of the 2nd, 6th, 10th, 12th, 14th, 18th, 22nd, and 28th weeks;FVC% at the end of the 6th, 10th, 12th, 14th, 18th, 22nd, and 28th weeks;Grip strength at the end of the 2nd, 6th, 10th, 12th, 14th, 18th, 22nd, and 28th weeks;Intravenous plasma neurofilament light chain content at the end of the 10th and 22nd weeks;Neuromuscular electrophysiologic studies at the end of the 10th and 22nd weeks;Permanent invasive respiration or oxygen assistance/death; | — |
Countries
China
Contacts
Public ContactXue Qun
The First Affiliated Hospital of Soochow University
Outcome results
None listed