Trial of Amivita in Amyotrophic Lateral Sclerosis

Not Applicable

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Drug: Amivita

• Registration Number: NCT03103815
• Lead Sponsor: Wujin People's Hospital

Brief 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.

Detailed Description

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder affecting upper and lower motor neurons. Survival is typically 2 to 5 years from symptom onset; death is usually from respiratory paralysis. Standard therapy is with Riluzole 100 mg/day, a FDA approved treatment for ALS that has a small effect on survival. There is a strong need for more effective therapies in ALS.

In our previous studies, we have shown that Amivita, a compound of amino acids and vitamines, is effective for neuronal injury (unpublished data). We have since then use this regimen to treat ALS patients. Our retrospective analysis (unpublished data) of the treated patient indicates that this regimen can slow down the progression of ALS.

We proposed a self-controlled clinical trial to study the safety and efficacy of Amivita. Secondary outcome measures include weight and quality of life. Twenty subjects in our ALS center who are already receiving riluzole will receive treatment for 12 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. Secondary outcome measures include body weight, forced vital capacity (FVC), quality of life and grip strength.

The total study length from first enrolled subject will be approximately 6 months.

Participants in this study will be subjects with familial or sporadic ALS diagnosed as probable, or definite, according to the World Federation of Neurology El Escorial criteria. Diagnostic and Inclusionary/Exclusionary criteria will be clearly outlined in the protocol.

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-01
• Study First Submitted QC: 2017-04-01
• Study First Posted: 2017-04-06
• Study Start: 2017-04-24
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2018-10-20
• Study Completion: 2018-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	Amivita	Experimental group will receive Amivita.

Primary Outcome Measures

Name	Time	Method
ALS Functional Rating Scale-Revised (ALSFRS-R) score	10 months	The ALSFRS is a validated clinical rating scale that has been shown to accurately track progression of patients disability in ALS. Inclusion of assessment of ALSFRS-R score is an essential element of the ALS trial.; design of ALS clinical trials
Adverse event	10 months	Significant adverse events in gastrointestinal and respiratory symptoms will be written in the adverse event log. Safety laboratory studies will be drawn and site investigators will be notified by their clinical laboratories if there are any changes in the chemistry and liver functions tests.

Secondary Outcome Measures

Name	Time	Method
Forced vital capacity (FVC)	10 months	Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters. FVC is an sensitive test for ALS patient' muscle ability.
EQ-5D	10 months	EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple measure of health for clinical appraisal.

Trial Locations

Locations (1)

Wujing People's Hospital; 🇨🇳 Changzhou, Jiangsu, China