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Open Label Study: Treatment of ALS Fatigue With PolyMVA

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ClinicalTrials.gov Identifier: NCT04557410
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborator:
Band of Hope Foundation
Information provided by (Responsible Party):
Raghav Govindarajan, University of Missouri-Columbia

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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: PolyMVA Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Open Label Study: Treatment of ALS Fatigue With PolyMVA
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021


Arm Intervention/treatment
Experimental: Receiving Supplement
Participants receive supplement PolyMVA. Dose is 2 teaspoons twice a day.
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.





Primary Outcome Measures :
  1. Change in fatigue severity [ Time Frame: Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in impact of fatigue [ Time Frame: Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks ]
    Modified Fatigue Impact Scale (MFIS), a 21-item rating scale with total scores ranging from 0 - 64 where the highest score reflects a greater impact of fatigue on a person's daily activity. Cam also be broken down into subscales: physical, cognitive, and psychosocial impacts.

  2. Change in severity of depression [ Time Frame: Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks ]
    Montgomery and Asberg Depression Rating Scale (MADRS), a scoring system used by the investigator based on a 10-item clinical interview moving from broadly phrased questions about symptoms to more detailed ones which allow a precise rating of severity. The rating are either given based on defined scale steps (0, 2, 4, 6) or between them (1,3,5), where higher scores indicate more severe depression (possible score is 0 - 60).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557410


Contacts
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Contact: Amer Avdagic, BS 5738821515 aath6@health.missouri.edu

Locations
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United States, Missouri
University of Missouri-Columbia School of Medicine Recruiting
Columbia, Missouri, United States, 65212
Contact: Raghav Govindarajan, MD       govindarajanr@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Band of Hope Foundation
Investigators
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Principal Investigator: Raghav Govindarajan, MD University of Missouri School of Medicine
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Responsible Party: Raghav Govindarajan, Professor and Principal Investigator, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04557410    
Other Study ID Numbers: 2022342
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Fatigue
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases