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NCT04635891 · ClinicalTrials.gov registry record

Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)

A clinical trial of FSHD, sponsored by University of Kansas Medical Center.

Recruiting
Registry status
450
Enrollment target
20
Study locations

NCT04635891: Recruiting study of FSHD, sponsored by University of Kansas Medical Center.

NCT04635891 is a study of FSHD that is actively recruiting participants, run by University of Kansas Medical Center. The registered enrollment target is 450 participants, below the 1,763-participant average among 3 other FSHD trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04635891, a study of FSHD, is actively recruiting participants, sponsored by University of Kansas Medical Center.

RECRUITING
Registry status
450 participants
Enrollment target
20
Study locations

Study Summary

The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level of clinical care is being provided. Also, the hope is to speed up drug development by gaining a better understanding of how having FSHD impacts motor function and other health outcomes (i.e. breathing, wheelchair use, etc.) and how big a change in motor function would be clinically meaningful to those with FSHD. Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) will have approximately 450 FSHD participants followed for a minimum of 3 years. A subset of MOVE FSHD participants, approximately 200, will participate in the MOVE+ sub-study which includes whole body MRI and reachable workspace, as well as optional muscle biopsy and wearable device (US participants only).

Primary Outcome

The 10-meter walk/run (previously the 30 foot go) or gait speed task will be performed during study visits. This task tests a range of different abilities, from power, to endurance, and balance. Also, the 10 meter walk/run is a predictor of loss of ambulation in Duchenne Muscular Dystrophy.

Conditions Studied

Study Locations (20)

Texas

  • Austin Neuromuscular Center - Austin
  • Univeristy of Texas Southwestern Medical Center - Dallas
  • University of Texas Health San Antonio - San Antonio

California

  • David Geffen School of Medicine at UCLA - Los Angeles
  • Neuromuscular Disorders Program at Stanford University School of Medicine - Stanford

Colorado

  • University of Colorado Anschutz Medical Campus - Aurora

Florida

  • Univeristy of Florida Gainesville - Gainesville

Iowa

  • University of Iowa - Iowa City

Kansas

  • Univeristy of Kansas Medical Center - Kansas City

Maryland

  • Kennedy Krieger Institute - Baltimore

New York

  • University of Rochester Medical Center - Rochester

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2020-12-15
Est. Completion 2028-01
University of Kansas Medical Center

408 total trials

What NCT04635891 shows while recruiting

NCT04635891 is an observational study that tracks outcomes without assigning an intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 1,763-participant average among 3 other FSHD trials with a reported enrollment target (74% lower).

The record links to 1 condition, with FSHD appearing as the primary indexed condition, and to 0 interventions.

NCT04635891 names 20 study sites across 17 states, led by Texas, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT04635891 about?

NCT04635891 is a clinical study titled "Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)". The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level of clinical care is being provided. Also, the hope is to speed up drug development by gaining a better understanding...

What is the current status of trial NCT04635891?

This trial is currently recruiting. The enrollment target is 450 participants. The study started on 2020-12-15. Estimated completion is 2028-01.

What conditions does trial NCT04635891 study?

This clinical trial studies the following conditions: FSHD.

Who is sponsoring clinical trial NCT04635891?

This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04635891 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for FSHD

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT04635891, the US trial registry maintained by the National Library of Medicine. NCT04635891 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.