Open Label Study: Treatment of ALS Fatigue With PolyMVA
Open Label Study: Treatment of ALS Fatigue With PolyMVA
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.
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.
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