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NCT03458832 · ClinicalTrials.gov registry record

Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD

A clinical trial of Facioscapulohumeral Muscular Dystrophy, sponsored by University of Kansas Medical Center.

Recruiting
Registry status
320
Enrollment target
14
Study locations

NCT03458832 is a study of Facioscapulohumeral Muscular Dystrophy that is actively recruiting participants, run by University of Kansas Medical Center. The registered enrollment target is 320 participants, below the 1,459-participant average among 6 other Facioscapulohumeral Muscular Dystrophy trials with a reported enrollment target (78% lower). The trial reports 14 study locations across 9 states.

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The verdict

NCT03458832, a study of Facioscapulohumeral Muscular Dystrophy, is actively recruiting participants, sponsored by University of Kansas Medical Center.

RECRUITING
Registry status
320 participants
Enrollment target
14
Study locations

Study Summary

The primary cause of facioscapulohumeral muscular dystrophy (FSHD), a common adult-onset dystrophy, was recently discovered identifying targets for therapy. As multiple drug companies pursue treatments for FSHD, there is an urgent need to define the clinical trial strategies which will hasten drug development, including creating disease-relevant outcome measures and optimizing inclusion criteria. This proposal will develop two new outcome measures (FSHD-COM and EIM) and optimize eligibility criteria by testing 320 patients across 14 international sites over a period of 24 months.

Interventions

  • DIAGNOSTIC_TEST FSHD-specific functional rating scale
  • DEVICE Electrical Impedance Myography

Study Locations (14)

Other

  • Chu De Nice - Nice
  • Institut de Myologie - Paris
  • Ludwig-Maximilians-Universität München - München
  • Centro Clinico NeMO - Milan
  • Radboud Unviersity - Nijmegen
  • University of College London - Queens Square - London

California

  • University of California Los Angeles - Los Angeles

Kansas

  • University of Kansas Medical Center - Kansas City

Maryland

  • Kennedy Krieger Institute - Baltimore

New York

  • University of Rochester Medical Center - Rochester

Ohio

  • The Ohio State University - Columbus

Utah

  • University of Utah - Salt Lake City

Virginia

  • Virginia Commonwealth University - Richmond

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2018-03-05
Est. Completion 2027-12

Sponsor

University of Kansas Medical Center

408 total trials

What the Registry Record Tells You About NCT03458832

The ClinicalTrials.gov registry entry for NCT03458832 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,459-participant average among 6 other Facioscapulohumeral Muscular Dystrophy trials with a reported enrollment target (78% lower). The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Facioscapulohumeral Muscular Dystrophy appearing as the primary indexed condition, and to 2 interventions - of which FSHD-specific functional rating scale is the first listed.

NCT03458832 reports 14 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Kansas.

Frequently Asked Questions

What is clinical trial NCT03458832 about?

NCT03458832 is a clinical study titled "Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD". The primary cause of facioscapulohumeral muscular dystrophy (FSHD), a common adult-onset dystrophy, was recently discovered identifying targets for therapy. As multiple drug companies pursue treatments for FSHD, there is an urgent need to define the clinical trial strategies which will hasten drug d...

What is the current status of trial NCT03458832?

This trial is currently recruiting. The enrollment target is 320 participants. The study started on 2018-03-05. Estimated completion is 2027-12.

What conditions does trial NCT03458832 study?

This clinical trial studies the following conditions: Facioscapulohumeral Muscular Dystrophy.

What interventions are being tested in trial NCT03458832?

The interventions under investigation include: FSHD-specific functional rating scale (DIAGNOSTIC_TEST), Electrical Impedance Myography (DEVICE).

Who is sponsoring clinical trial NCT03458832?

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

Where is trial NCT03458832 being conducted?

This trial has 14 study locations across California, Kansas, Maryland, New York, Ohio. 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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