Back to resultsExplore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
lipoic acid group
control group
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
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;
Sites / Locations
- Second Affiliated Hospital,Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
lipoic acid group
control group
Arm Description
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 riluzole tablets orally everyday.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 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 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 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 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 .
Full Information
NCT ID
NCT04518540
First Posted
August 5, 2020
Last Updated
August 17, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04518540
Brief Title
Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis
Official Title
Randomized, Parallel Safety and Efficacy Study of Lipoic Acid in Patients With Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
outcomes assessors who do all the scales are concealed of group allocation.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lipoic acid group
Arm Type
Experimental
Arm Description
The patients will take lipoic acid by intravenous. At the same time, the patients will take take riluzole tablets orally everyday.
Arm Title
control group
Arm Type
Experimental
Arm Description
The patients will take riluzole tablets orally everyday.
Intervention Type
Drug
Intervention Name(s)
lipoic acid group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
control group
Intervention Description
The patients will take domestic riluzole tablets 50mg orally, twice a day.
Primary Outcome Measure Information:
Title
change of Amyotrophic lateral sclerosis Function Rate Scale-Revised (ALSFRS-R)
Description
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.
Time Frame
change from baseline to 11th week& 21th week
Secondary Outcome Measure Information:
Title
change of Rasch Overall ALS Disability Scale (ROADS)
Description
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.
Time Frame
change from baseline to 11th week& 21th week
Title
change of Upper motor neuron scale (UMNS)
Description
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.
Time Frame
change from baseline to 11th week& 21th week
Title
change of Muscle strength scale
Description
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.
Time Frame
change from baseline to 11th week& 21th week
Title
change of Pulmonary Forced Vital Capacity (PFVC)
Description
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.
Time Frame
change from baseline to 11th week& 21th week
Title
change of Motor Neuron Disease Electromyography
Description
Motor Neuron Disease Electromyography will be performed to test the electrical activity of muscles of patients at the enrollment, 3th course and 6th course .
Time Frame
change from baseline EMG to 21th week
Other Pre-specified Outcome Measures:
Title
Endpoint events occur rate
Description
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);
Time Frame
at 21th week
Title
percentage of adverse drug reaction
Description
Check the percentage of adverse drug reactions in blood routine, blood biochemistry, and urine routine
Time Frame
At the baseline, 11th week and 21th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhiying wu, Ph.D
Phone
13646715353
Email
zhiyingwu@zju.edu.cn
Facility Information:
Facility Name
Second Affiliated Hospital,Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Ying Wu, MD&PhD
Phone
+86-571-87783569
Email
zhiyingwu@zju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis
We'll reach out to this number within 24 hrs