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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 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.

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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.

Interventions

  • DRUG PolyMVA

Study Locations (1)

Missouri

  • University of Missouri-Columbia School of Medicine - Columbia

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2020-09-23
Est. Completion 2021-05-25
Phase Phase 1

Sponsor

University of Missouri-Columbia

291 total trials

What the Registry Record Tells You About NCT04557410

The ClinicalTrials.gov registry entry for NCT04557410 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (99% lower). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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