Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Randomized, Parallel Safety and Efficacy Study of Lipoic Acid in Patients With Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04518540
• Other study ID #: 2020-375
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: August 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: zhiying wu, Ph.D
• Phone: 13646715353
• Email: zhiyingwu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
China	Second Affiliated Hospital,Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Endpoint events occur rate	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
Other	percentage of adverse drug reaction	Check the percentage of adverse drug reactions in blood routine, blood biochemistry, and urine routine	At the baseline, 11th week and 21th week
Primary	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.	change from baseline to 11th week& 21th week
Secondary	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 from baseline to 11th week& 21th week
Secondary	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 from baseline to 11th week& 21th week
Secondary	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 from baseline to 11th week& 21th week
Secondary	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 from baseline to 11th week& 21th week
Secondary	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 .	change from baseline EMG to 21th week