amyotrophic lateral sclerosis
Conditions
Interventions
Low-dose group:Pomidone 5mg 3 times a day
High dose group:Pomidone 10mg 3 times a day
Control group:Placebo 3 times a day
Sponsors
The First Hospital of Yichang
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or more; 2.Patients with a diagnosis of possible, laboratory-supported probable,probable, or definite amyotrophic lateral sclerosis in accordance with the 1998 revised El Escorial criteria; 3.Course of disease from onset to enrollment <=24 months (onset date was first muscle weakness, excluding bundle tremor and spasm); 4.Subjects who can take oral medication or receive oral medication; 5.Signed consent form; 6.Willing or unable to participate in and complete the study.
Exclusion criteria
Exclusion criteria: 1.Participated in other clinical studies within 3 months; 2.Endotracheal intubation or invasive assisted ventilation; 3.Gastrostomy or dysphagia; 4.Pregnant women and lactating women; 5.People allergic to primidone; 6.ALT or AST was 3 times higher than normal; 7.Creatinine clearance rate was less than 50ml/min; 8.Disease or injury that interferes with functional assessment or endangers life; 9.Any known motor neurone disease unrelated to ALS; 10.Major mental illness, cognitive dysfunction; 11.Irregular history of taking medicine in the past 3 years; 12.Patients with altered vision, diplopia, nystagmus or ataxia; 13.Patients with porphyria; 14.Patients with asthma, chronic obstructive pulmonary disease or other respiratory disease that may aggravate breathing difficulties or obstructed airways. 15.People with coagulation dysfunction; 16.Patients with impaired liver and kidney function; Albuminuria showed ++ and above; 17.Systolic blood pressure less than 90 mmHg, diastolic pressure less than 50 mmHg, heart rate less than 50 beats per minute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved amyotrophic lateral sclerosis (ALS) function score;Forced vital capacity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Norris scale score;ALSAQ-40 score;Change in hand-held dynamometry;Duration from onset to invasive ventilation/bed rest;Survival rate; | — |
Countries
China
Contacts
Public ContactZha Yunhong
The First Hospital of Yichang
Outcome results
None listed