Open Label Study: Treatment of ALS Fatigue With PolyMVA

Open Label Study: Treatment of ALS Fatigue With PolyMVA

Sponsors

Lead Sponsor: University of Missouri-Columbia

Collaborator: Band of Hope Foundation

Source 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.

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.

Overall Status Not yet recruiting
Start Date September 25, 2020
Completion Date May 1, 2021
Primary Completion Date May 1, 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in fatigue severity Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks
Secondary Outcome
Measure Time Frame
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
Enrollment 15
Condition
Intervention

Intervention Type: Drug

Intervention Name: PolyMVA

Description: 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.

Arm Group Label: Receiving Supplement

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Raghav Govindarajan, MD Principal Investigator University of Missouri School of Medicine
Overall Contact

Last Name: Amer Avdagic, BS

Phone: 5738821515

Email: [email protected]

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Missouri-Columbia

Investigator Full Name: Raghav Govindarajan

Investigator Title: Professor and Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Receiving Supplement

Type: Experimental

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

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov