drugset / Trial / NCT04518540

Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis

NCT04518540

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject alpha-lipoic acid Small molecule 600 mg Intravenous
Background Riluzole Small molecule 50 mg Oral