Open Label Study: Treatment of ALS Fatigue With PolyMVA

NCT ID: NCT04557410

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2021-05-25

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.

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Receiving Supplement

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

Group Type: EXPERIMENTAL

PolyMVA

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Band of Hope Foundation

UNKNOWN

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Raghav Govindarajan

Professor and Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raghav Govindarajan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri School of Medicine

Locations

University of Missouri-Columbia School of Medicine

Columbia, Missouri, United States

Countries

United States

Other Identifiers

2022342

Identifier Type: -

Identifier Source: org_study_id