Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis

NCT ID: NCT04518540

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-10-01

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

lipoic acid group

The patients will take lipoic acid by intravenous. At the same time, the patients will take take riluzole tablets orally everyday.

Group Type: EXPERIMENTAL

lipoic acid group

Intervention Type: DRUG

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 riluzole tablets orally everyday.

Group Type: EXPERIMENTAL

control group

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

control group

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

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Second Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

zhiying wu, Ph.D

Role: CONTACT

zhiyingwu@zju.edu.cn

13646715353

Facility Contacts

Zhi-Ying Wu, MD&PhD

Role: primary

zhiyingwu@zju.edu.cn

+86-571-87783569

Other Identifiers

2020-375

Identifier Type: -

Identifier Source: org_study_id