Clinical trial NCT04557410: Open Label Study: Treatment of ALS Fatigue With PolyMVA
Official title: Open Label Study: Treatment of ALS Fatigue With PolyMVA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Band of Hope Foundation
First posted: 2020-09-21
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in fatigue severity
timeFrame: Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks
Secondary outcomes:
measure: Change in impact of fatigue
timeFrame: Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks
measure: Change in severity of depression
timeFrame: Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia School of Medicine
state: Missouri
Study officials:
affiliation: University of Missouri School of Medicine
name: Raghav Govindarajan, MD
role: PRINCIPAL_INVESTIGATOR
References: