Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis
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ClinicalTrials.gov Identifier: NCT04518540 |
Recruitment Status : Unknown
Verified August 2020 by Second Affiliated Hospital, School of Medicine, Zhejiang University.
Recruitment status was: Recruiting
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
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Condition or disease | Intervention/treatment | Phase |
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Amyotrophic Lateral Sclerosis | Drug: lipoic acid group Drug: control group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Masking Description: | outcomes assessors who do all the scales are concealed of group allocation. |
Primary Purpose: | Treatment |
Official Title: | Randomized, Parallel Safety and Efficacy Study of Lipoic Acid in Patients With Amyotrophic Lateral Sclerosis |
Estimated Study Start Date : | September 1, 2020 |
Estimated Primary Completion Date : | September 1, 2022 |
Estimated Study Completion Date : | October 1, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: lipoic acid group
The patients will take lipoic acid by intravenous. At the same time, the patients will take take riluzole tablets orally everyday.
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Drug: lipoic acid group
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. |
Experimental: control group
The patients will take riluzole tablets orally everyday.
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Drug: control group
The patients will take domestic riluzole tablets 50mg orally, twice a day. |
- change of Amyotrophic lateral sclerosis Function Rate Scale-Revised (ALSFRS-R) [ Time Frame: change from baseline to 11th week& 21th week ]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 of Rasch Overall ALS Disability Scale (ROADS) [ Time Frame: change from baseline to 11th week& 21th week ]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 of Upper motor neuron scale (UMNS) [ Time Frame: change from baseline to 11th week& 21th week ]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 of Muscle strength scale [ Time Frame: change from baseline to 11th week& 21th week ]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 of Pulmonary Forced Vital Capacity (PFVC) [ Time Frame: change from baseline to 11th week& 21th week ]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 of Motor Neuron Disease Electromyography [ Time Frame: change from baseline EMG to 21th week ]Motor Neuron Disease Electromyography will be performed to test the electrical activity of muscles of patients at the enrollment, 3th course and 6th course .
- Endpoint events occur rate [ Time Frame: at 21th week ]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);
- percentage of adverse drug reaction [ Time Frame: At the baseline, 11th week and 21th week ]Check the percentage of adverse drug reactions in blood routine, blood biochemistry, and urine routine

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age range from 20 to 75 (including 20 and 75 years old), regardless of ethnic group or gender;
- The subjects should meet the diagnostic criteria for ALS by El Escorial revised criteria: "Definite ALS", "Probable ALS" and "Probable, laboratory-supported ALS".
- ALS Functional Rating Scale-Revised (ALSFRS-R 12 items) each item score ≥2 points;
- The onset (the symptoms of limbs weakness, muscle atrophy or bulbar involvement ) of the disease is less than 2 years
- Baseline breath function: Forced Vital Capacity≥70% .
- Disease Progression Rate FS=(48- ALSFRS-R at "time of diagnosis")/duration from onset to diagnosis (month), progression rate FS≤1;
Exclusion Criteria:
- Combined with one of cerebrovascular disease, spinal cord disease, spinal muscular atrophy, juvenile myoatrophy of distal upper extremity, multifocal motor neuropathy, Kennedy disease, epilepsy, etc;
- Severe renal insufficiency: creatinine clearance rate <30 mL/min (Cockcroft-Gault formula, urea nitrogen and (or) blood creatinine> 1.5 times the upper limit of normal, or other known severe renal insufficiency diseases;
- Severe liver damage: ALT, AST> 3 times the upper limit of normal, or other known liver diseases such as acute and chronic hepatitis, cirrhosis, etc.;
- Obvious tachycardia or bradycardia; patients with acute myocardial infarction or interventional therapy in the past 6 months (patients with grade III-IV according to NYHA classification);
- Combined with malignant tumor, blood, digestion or other serious diseases;
- Female patients during pregnancy and lactation;
- Participated in other clinical trials within 30 days before randomization, or are participating in other clinical trials;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518540
Contact: zhiying wu, Ph.D | 13646715353 | zhiyingwu@zju.edu.cn |
China, Zhejiang | |
Second Affiliated Hospital,Zhejiang University School of Medicine | Recruiting |
Hangzhou, Zhejiang, China, 310009 | |
Contact: Zhi-Ying Wu, MD&PhD +86-571-87783569 zhiyingwu@zju.edu.cn |
Responsible Party: | Second Affiliated Hospital, School of Medicine, Zhejiang University |
ClinicalTrials.gov Identifier: | NCT04518540 |
Other Study ID Numbers: |
2020-375 |
First Posted: | August 19, 2020 Key Record Dates |
Last Update Posted: | August 19, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies |
Proteostasis Deficiencies Metabolic Diseases Thioctic Acid Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients |