MedTrace Logo

Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis

NCT04518540 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-08-19

No results posted yet for this study

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

Interventions

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.

DRUG

control group

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

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-09-01
Completion
2022-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04518540 on ClinicalTrials.gov