Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis

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

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

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital,Zhejiang University School of Medicine
        • Contact:

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:

  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;

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.
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.
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.
change from baseline to 11th week& 21th week
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 .
change from baseline EMG to 21th week

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);
at 21th week
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
At the baseline, 11th week and 21th week

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

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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