Trial of Amivita in Amyotrophic Lateral Sclerosis

• Status: Unknown status
• Trial end date: 2018-10-20
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wujin People's Hospital
• Collaborators: Nanjing 1718 Biotech Co. Ltd; Nanjing Bioheng Biotech Co., Ltd.

Criteria

Inclusion Criteria

• Patients must be men or women between the ages of 18 and 70 years

• Patient is clinical definite or probable ALS by the hospitals listed in the protocol

• Women who are of child bearing potential must have a negative pregnancy test

• Willing to comply with the study visits

• Will not take riluzole during the study period

• Be able to sign informed consent document

Exclusion Criteria

• Myotonic dystrophy

• Myasthenia gravis

• Post-poliomyelitis syndrome

• Multifocal motor neuropathy with or without conduction block

• Hirayama disease

• Kennedy disease

• Hereditary spastic paraplegia

• Syringomyelia

• Spinal cord and brain stem tumors

• Paraneoplastic syndromes

• Severe liver or kidney disease disease

• Infection, severe diarrhea or vomiting

• Serious heart or lung diseases or malignant tumor history

• HIV infection

• Pregnancy or breastfeeding

• Have no ability to communicate

• Have participated in other clinical trials within 4 weeks

• Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study