Overview

Trial of Amivita in Amyotrophic Lateral Sclerosis

Status:
Unknown status
Trial end date:
2018-10-20
Target enrollment:
Participant gender:
Summary
The primary objectives of this study are to determine the safety and efficacy of Amivita, a compound of amino acids and vitamines in patients with Amyotrophic lateral sclerosis (ALS)ALS. The secondary objectives are to measure quality of life before and during intervention. This is a self-controlled clinical trial. Twenty patients in our ALS center who are already receiving riluzole or other treatments but the condition is worsening will receive treatment for 1o months. The evaluating investigators will be blinded to treatment assignment. Primary outcome measures will be adverse events, the ALS Functional Rating Scale-Revised (ALSFRS-R), and survival. Subjects will also be assessed at enrollment and at study end for weight loss, forced vital capacity (FVC), quality of life and grip strength.
Phase:
N/A
Details
Lead Sponsor:
Wujin People's Hospital
Collaborators:
Nanjing 1718 Biotech Co. Ltd
Nanjing Bioheng Biotech Co., Ltd.