Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis

NCT04518540 | Unknown

• 1 other identifier: 2020-375
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• change of Rasch Overall ALS Disability Scale (ROADS)

  change from baseline to 11th week& 21th week

• change of Upper motor neuron scale (UMNS)

  change from baseline to 11th week& 21th week

• change of Muscle strength scale

  change from baseline to 11th week& 21th week

• change of Pulmonary Forced Vital Capacity (PFVC)

  change from baseline to 11th week& 21th week

• change of Motor Neuron Disease Electromyography

  change from baseline EMG to 21th week

Other Outcomes (2)

• Endpoint events occur rate

  at 21th week

• percentage of adverse drug reaction

  At the baseline, 11th week and 21th week

Study Arms (2)

lipoic acid group

EXPERIMENTAL

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

Drug: lipoic acid group

control group

EXPERIMENTAL

The patients will take riluzole tablets orally everyday.

Drug: control group

Interventions

lipoic acid group 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.

lipoic acid group

control group DRUG

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

control group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

zhiying wu, Ph.D

CONTACT

13646715353; zhiyingwu@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes assessors who do all the scales are concealed of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 19, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

CN (1)