Open Label Study: Treatment of ALS Fatigue With PolyMVA

NCT04557410 | Completed Phase 1

• 1 other identifier: 2022342
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in fatigue severity

  Subjects will be assessed for fatigue using the Amyotrophic Lateral Sclerosis Functional Rating Scale - Respiratory (ALSFRS-R), a 12-item scale with possible scores ranging from 0 - 48 where 0 = total dependence and 48 = normal function.

  Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks

Secondary Outcomes (2)

• Change in impact of fatigue

  Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks

• Change in severity of depression

  Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks

Study Arms (1)

Receiving Supplement

EXPERIMENTAL

Participants receive supplement PolyMVA. Dose is 2 teaspoons twice a day.

Drug: PolyMVA

Interventions

PolyMVA DRUG

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.

Receiving Supplement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Definite ALS
• Severe fatigue (defined by FSS \> 4.0)
• Expanded Disability Status Scale (EDSS) (measure of neurological impairment) 0 - 7.5 Able to comply with study procedures
• Stable medication for the past month prior to enrollment.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Band of Hope Foundation: collaborator

Study Sites (1)

University of Missouri-Columbia School of Medicine

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Raghav Govindarajan, MD

  University of Missouri School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Principal Investigator

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: September 21, 2020
• Study Start: September 23, 2020
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-04

Locations

US (1)