Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this proposed study, the investigators will evaluate the safety and efficacy of lipoic acid in treatment of Amyotrophic lateral sclerosis (ALS). The study will recruit 150 AD patients, and then these patients will be randomized to lipoic acid group or control group (75 patients per arm) for 6 courses for about 5 months. Clinical assessment will be done at screen/baseline, 3th course and 6th course. The specific aims are to compare lipoic acid versus control on: motor function and disease progression. During the study period, clinical effect index will be recorded, including bulbar function, motor function, respiratory function, and safety index including blood and urine routine, liver and kidney function, coagulation function.
In this proposed study, the investigators will evaluate the safety and efficacy of Lipoic acid in treatment of ALS. The study will recruit 150 ALS patients, then these patients will be randomized to lipoic acid group or control group (75 patients per arm) for 6 courses for about 5 months. Clinical efficacy and safety assessment will be done at screen/baseline, 3th course and 6th course. The specific aims are to compare lipoic acid versus placebo on: (1) Lipoic acid could improve the motor function, delay the disease progression and extend survival time in patients with ALS, measured by the ALSFRS-R Scale, ROADS Scale, upper motor neuron Scale, Muscle strength Scale and Electromyography; (2) Lung function will be collected to prove the hypothesis lipoic acid may help respiratory function. (3) Safety index including blood and urine routine, liver and kidney function, coagulation index will be recorded.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lipoic acid group | Experimental | The patients will take lipoic acid by intravenous. At the same time, the patients will take take riluzole tablets orally everyday. |
|
| control group | Experimental | The patients will take riluzole tablets orally everyday. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lipoic acid group | Drug | The patients will take lipoic acid for 6 course, the first course of treatment is 14 days with 14 days of rest, and the following course is the first for 10 days, with 14 days interval.The patients will use 600mg domestic lipoic acid in 250ml normal saline by intravenous, once a day. At the same time, the patients will take domestic riluzole tablets 50mg orally, twice a day. |
| Measure | Description | Time Frame |
|---|---|---|
| change of Amyotrophic lateral sclerosis Function Rate Scale-Revised (ALSFRS-R) | The Amyotrophic lateral sclerosis Function Rate Scale-Revised (ALSFRS-R) will be performed to test the motor function of patients at the enrollment, 3th course and 6th course . The score ranges from 0 to 48#and higher scores represent a better motor function. | change from baseline to 11th week& 21th week |
| Measure | Description | Time Frame |
|---|---|---|
| change of Rasch Overall ALS Disability Scale (ROADS) | Rasch Overall ALS Disability Scale (ROADS) will be performed to test the motor function of patients at the enrollment, 3th course and 6th course . The score ranges from 0 to 56#and higher scores represent a better motor function. | change from baseline to 11th week& 21th week |
| Measure | Description | Time Frame |
|---|---|---|
| Endpoint events occur rate | Endpoint events occur rate, including death, tracheotomy, invasive ventilator assisted ventilation or continuous noninvasive ventilator assisted ventilation (use time ≥22 hours per day, duration ≥10 days); | at 21th week |
| percentage of adverse drug reaction |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhiying wu, Ph.D | Contact | 13646715353 | zhiyingwu@zju.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital,Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
Not provided
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
outcomes assessors who do all the scales are concealed of group allocation.
|
| control group | Drug | The patients will take domestic riluzole tablets 50mg orally, twice a day. |
|
| change of Upper motor neuron scale (UMNS) |
Upper motor neuron scale(UMNS) will be performed to test the motor function of patients at the enrollment, 3th course and 6th course . The score ranges from 0 to 33. |
| change from baseline to 11th week& 21th week |
| change of Muscle strength scale | Muscle strength scale will be performed to test the muscle strength of patients at the enrollment, 3th course and 6th course. Higher scores represent a better muscle strength. | change from baseline to 11th week& 21th week |
| change of Pulmonary Forced Vital Capacity (PFVC) | Pulmonary Forced Vital Capacity (PFVC) will be performed to test the breath function of patients at the enrollment, 3th course and 6th course. Higher scores represent a better pulmonary function. | change from baseline to 11th week& 21th week |
| change of Motor Neuron Disease Electromyography | Motor Neuron Disease Electromyography will be performed to test the electrical activity of muscles of patients at the enrollment, 3th course and 6th course . | change from baseline EMG to 21th week |
Check the percentage of adverse drug reactions in blood routine, blood biochemistry, and urine routine |
| At the baseline, 11th week and 21th week |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008722 | Methods |