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Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD
NCT03458832 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2018-03-05 |
| Est. Completion | 2027-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03458832
The ClinicalTrials.gov registry entry for NCT03458832 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 454 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03458832 reports 14 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03458832?
The interventions under investigation include: FSHD-specific functional rating scale (DIAGNOSTIC_TEST), Electrical Impedance Myography (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03458832?
This trial is sponsored by University of Kansas Medical Center, which has 454 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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