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Open Label Study: Treatment of ALS Fatigue With PolyMVA

NCT04557410 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-05-27

No results posted yet for this study

Summary

Amyotrophic lateral sclerosis (ALS) is a disease that causes the death of upper and lower motor neurons. ALS symptoms are characterized by stiffness, muscle twitching, and worsening weakness due to muscle breakdown. Onset of symptoms are typically arm or leg weakness or difficulty speaking or swallowing and gradual development of overall body weakness. The cause is unknown and there is no cure for ALS.

Poly MVA was found to substantially lower fatigue and improve quality of life in a pilot study of patients with varied medical disorders. The reduction in fatigue was also observed in a small series of patients enrolled in an open label study for patients with gliomas.

In this study, we want to find out more about a dietary supplement, called Poly MVA (also called the study drug in this form), for people with ALS. We want to find out if Poly MVA reduces the symptoms of fatigue and depression when taken daily. The supplement contains vitamins, minerals and amino acids (proteins) and has been used by patients with other medical conditions to help with their fatigue and quality of life.

Conditions

Interventions

DRUG

PolyMVA

One-half teaspoon of PolyMVA contains the following: * Daily Value Thiamin (B-1) 23mg 1,533 Riboflavin (B-2) 0.45mg 26 Vitamin B-12 460mcg 7,666 Proprietary Blend 32mg - contains the following ingredients (no FDA value has been established on any of the following): Palladium, Alpha Lipoic Acid, Molybdenum, Rhodium, Ruthenium, Formyl Methionine, N-acetyl Cysteine. For each ml of Poly-MVA, the exact dosages are as follows: Palladium: 3.97mg Molybdenum: 0.044mg Ruthenium: 0.0014mg Rhodium: 0.014mg Lipoic Acid: 7.68mg Thiamine (B1): 9.26mg Riboflavin (B2): 0.174mg B12: 0.185mg Formyl Methionine: 0.026mg N-Acetyl cysteine: 0.185mg Vitamin A acetate 100 IU Other Ingredients: Distilled water, purified water, thiamine hydrochloride, Vitamin B12 as cyanocobalamin.

Sponsors & Collaborators

  • Band of Hope Foundation

    collaborator UNKNOWN

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Raghav Govindarajan, MD · University of Missouri School of Medicine

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2021-05-25
Completion
2021-05-25

Countries

  • United States

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 NCT04557410 on ClinicalTrials.gov