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NCT04557410 · ClinicalTrials.gov registry record · Phase 1
Open Label Study: Treatment of ALS Fatigue With PolyMVA
A Phase 1 study of Amyotrophic Lateral Sclerosis, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04557410: Completed Phase 1 study of Amyotrophic Lateral Sclerosis, sponsored by University of Missouri-Columbia.
NCT04557410 is a Phase 1 study of Amyotrophic Lateral Sclerosis that has completed, run by University of Missouri-Columbia. The registered enrollment target is 12 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04557410, a Phase 1 study of Amyotrophic Lateral Sclerosis, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG PolyMVA
Study Locations (1)
Missouri
- University of Missouri-Columbia School of Medicine - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2021-05-25 |
| Phase | Phase 1 |
What the finished NCT04557410 record still lists
NCT04557410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which PolyMVA is the first listed.
NCT04557410 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04557410 about?
NCT04557410 is a clinical study titled "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 swallo...
What is the current status of trial NCT04557410?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-09-23. Estimated completion is 2021-05-25.
What conditions does trial NCT04557410 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT04557410?
The interventions under investigation include: PolyMVA (DRUG).
Who is sponsoring clinical trial NCT04557410?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04557410 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04557410's enrollment target sits among peer trials
12 88th of 102 higher than 14 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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