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Open Label Study: Treatment of ALS Fatigue With PolyMVA

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase I

Study Chair(s)/Principal Investigator(s):

Raghav Govindarajan, MD University of Missouri School of Medicine

Clinicaltrials.gov ID (11 digit #):

NCT04557410

Neals Affiliated?

No

Coordinating Center Contact Information

University of Missouri-Columbia School of Medicine
Amer Avdagic, BS / .(JavaScript must be enabled to view this email address) / 573-882-1515
.(JavaScript must be enabled to view this email address) Columbia, Missouri 65212 United States

Full 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 is a dietary supplement which contains a uniquely formulated combination of minerals, vitamins, and amino acids designed to promote cellular energy production. The active molecule in this supplement is Palladium Lipoic Acid (PdLA) complex. This compound is synthesized using a process whereby palladium (a rare metal, which is found in the food chain- we consume approximately 2 ng/day is chemically bound to alpha lipoic acid, a powerful anti-oxidant involved in cellular energy.

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.

Specific Aim 1: To test the efficacy of PolyMVA as a treatment for ALS fatigue.

Specific Aim 2: To determine the specificity of the fatigue reducing effect of Poly-MVA by controlling for mood, disease severity, and cognitive status

This is an open-label, prospective study which evaluates the response of 4 teaspoons of Poly MVA taken daily, over a 24-Week interval.

Study Sponsor:

University of Missouri-Columbia

Participant Duration:

Estimated Enrollment:

15

Estimated Study Start Date:

09/23/2020

Estimated Study Completion Date:

07/01/2021

Posting Last Modified Date:

11/23/2020

Date Study Added to alsconsortium.org:

11/23/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    N/A

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • na

  • Site Contact Information

    University of Missouri-Columbia School of Medicine
    Raghav Govindarajan, MD / .(JavaScript must be enabled to view this email address) / Columbia, Missouri 65212
    United States