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Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: lipoic acid group Drug: control group Not Applicable

Detailed Description:
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.

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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.
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.
Drug: control group
The patients will take domestic riluzole tablets 50mg orally, twice a day.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 .


Other Outcome Measures:
  1. 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);

  2. 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



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Age range from 20 to 75 (including 20 and 75 years old), regardless of ethnic group or gender;
  2. The subjects should meet the diagnostic criteria for ALS by El Escorial revised criteria: "Definite ALS", "Probable ALS" and "Probable, laboratory-supported ALS".
  3. ALS Functional Rating Scale-Revised (ALSFRS-R 12 items) each item score ≥2 points;
  4. The onset (the symptoms of limbs weakness, muscle atrophy or bulbar involvement ) of the disease is less than 2 years
  5. Baseline breath function: Forced Vital Capacity≥70% .
  6. Disease Progression Rate FS=(48- ALSFRS-R at "time of diagnosis")/duration from onset to diagnosis (month), progression rate FS≤1;

Exclusion Criteria:

  1. 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;
  2. 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;
  3. 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.;
  4. 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);
  5. Combined with malignant tumor, blood, digestion or other serious diseases;
  6. Female patients during pregnancy and lactation;
  7. Participated in other clinical trials within 30 days before randomization, or are participating in other clinical trials;

Information from the National Library of Medicine

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


Contacts
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Contact: zhiying wu, Ph.D 13646715353 zhiyingwu@zju.edu.cn

Locations
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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   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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