- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04518540
Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis
August 17, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Randomized, Parallel Safety and Efficacy Study of Lipoic Acid in Patients With Amyotrophic Lateral Sclerosis
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: zhiying wu, Ph.D
- Phone Number: 13646715353
- Email: zhiyingwu@zju.edu.cn
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Recruiting
- Second Affiliated Hospital,Zhejiang University School of Medicine
-
Contact:
- Zhi-Ying Wu, MD&PhD
- Phone Number: +86-571-87783569
- Email: zhiyingwu@zju.edu.cn
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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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The patients will take domestic riluzole tablets 50mg orally, twice a day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 from baseline to 11th week& 21th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 from baseline to 11th week& 21th week
|
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.
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change from baseline to 11th week& 21th week
|
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 from baseline to 11th week& 21th week
|
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.
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change from baseline to 11th week& 21th week
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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 .
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change from baseline EMG to 21th week
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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);
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at 21th week
|
percentage of adverse drug reaction
Time Frame: At the baseline, 11th week and 21th week
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Check the percentage of adverse drug reactions in blood routine, blood biochemistry, and urine routine
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At the baseline, 11th week and 21th week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
August 5, 2020
First Submitted That Met QC Criteria
August 17, 2020
First Posted (Actual)
August 19, 2020
Study Record Updates
Last Update Posted (Actual)
August 19, 2020
Last Update Submitted That Met QC Criteria
August 17, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Sclerosis
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin B Complex
- Thioctic Acid
Other Study ID Numbers
- 2020-375
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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