- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04557410
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri-Columbia School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Receiving Supplement
Participants receive supplement PolyMVA.
Dose is 2 teaspoons twice a day.
|
One-half teaspoon of PolyMVA contains the following:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fatigue severity
Time Frame: Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks
|
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.
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Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in impact of fatigue
Time Frame: Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks
|
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.
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Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks
|
Change in severity of depression
Time Frame: Baseline, 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Raghav Govindarajan, MD, University of Missouri School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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