Amyotrophic lateral sclerosis
Conditions
Interventions
Experimental group:D-cycloserine 100mg twice-daily
Placebo group:placebo 100mg twice-daily
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ALS patients who meet all of the following selection criteria and have the ability to consent. At the time of pre-registration: (1) patients who meet the "definite" or "probable" criteria of the revised Airlie House diagnostic criteria of El Escorial; (2) Patients with ALS severity 1 or 2 according to the King's College London staging system; (3) Patients with ALSFRS-R scores of 2 or above ((4)Writing and (5)Eating must be double A side score of 2 or more); (4) Normal respiratory function (%FVC>= 80%: judged by actual value); (5) Patients who committed to taking liluzole stably during the observation period and the double-blind treatment period; (6) patients who have had ALS for less than 2 years at the time of signing their written consent; (7) Patients aged between 18 and 75 at the time of obtaining written consent; (8) Patients who have given written consent to participate in this study. At the time of enrollment, patients who met the following criteria in addition to the selection criteria at the time of pre-enrollment were enrolled (9) Patients with ALSFRS-R scores ranging from -1 to -4 during the 12-week observation period.
Exclusion criteria
Exclusion criteria: Patients with ALS who met at least one of the following exclusion criteria were excluded from the study. For pre-registration: (1) Patients with respiratory impairment and complaints of dyspnea (ALSFRS-R: 1) dyspnea, 2) orthopnea, 3) respiratory failure with a score of 3 or less); (2) Patients with Parkinson's disease and its syndrome, schizophrenia, dementia or other comorbidities that may have a significant impact on the evaluation of drug efficacy; (3) severe renal insufficiency: creatinine clearance 3 times the upper limit of normal, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis, etc.; (5) Patients with acute myocardial infarction or percutaneous coronary intervention within the past 6 months or heart failure (NYHA class III-IV patients); (6) Patients with a history of cervical spondylosis, disc herniation, or other spinal surgery scheduled for surgery after ALS onset or during the study period; (7) Patients whose symptoms cannot exclude cervical spondylosis, multifocal motor neuropathy, or other diseases requiring differential diagnosis; (8) Allergic to cycloserine; (9) Patients with malignant tumors who were receiving treatment; (10) Patients receiving treatment for tuberculosis; (11)Patients with epilepsy history; (12) Patients with alcohol or alcoholism; (13) Severe complications (grade 3 according to the severity grading standard such as adverse drug reactions); (14) Patients who could not consent to use contraception during the trial; (15) Pregnant, lactating or likely pregnant women; (16) Patients enrolled in other clinical trials and receiving study drug treatment within 12 weeks before obtaining informed consent; (17) Patients taking edaravone; (18) Patients deemed unsuitable for the trial by the investigator or subinvestigator; At enrollment, the following patients were excluded (19) Patients who did not take riluzole regularly within one month before the end of the observation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;ALSFRS-R; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Norris scale;Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40);milestone events;Grip ;Blood concentration of D-cycloserine;pinch;pulmonary function;Plasma filament light chain protein; | — |
Countries
China
Contacts
Public ContactHuifang Shang
West China Hospital, Sichuan University
Outcome results
None listed