Open Label Study: Treatment of ALS Fatigue With PolyMVA

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Open Label Study: Treatment of ALS Fatigue With PolyMVA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557410
• Other study ID #: 2022342
• Status: Completed
• Phase: Phase 1
• Start date: September 23, 2020
• Est. completion date: May 25, 2021

Study information

• Verified date: April 2021
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Fatigue
• Motor Neuron Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University of Missouri-Columbia School of Medicine	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Band of Hope Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in impact of fatigue	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.	Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks
Secondary	Change in severity of depression	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).	Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks