NCT06425445

Brief Summary

The goal of this study is to validate a new method for the assessment of orofacial muscles in FSHD affected individuals

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

May 17, 2024

Last Update Submit

February 23, 2026

Conditions

Facioscapulohumeral Muscular Dystrophy

Outcome Measures

Primary Outcomes (1)

  • A performance index based on serial assessments of each participant

    Measurements will be performed for each study participant at visit 1 and subsequently at visit 2 (3 months later). The measurements as such, should take about 30 minutes for each participant

Study Arms (2)

Affected participants

EXPERIMENTAL
Procedure: Orofacial function assessment tests

Healthy participants

EXPERIMENTAL
Procedure: Orofacial function assessment tests

Interventions

Orofacial function assessment testsPROCEDURE

Participants undergo serial measurements for the assessment of orofacial function

Affected participantsHealthy participants

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Genetic diagnosis of FSHD type 1 and/or type 2

You may not qualify if:

  • Pregnant women
  • Presence of other associated neuromuscular conditions
  • Any unstable interfering clinical situation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mons

Mons, Hainaut, 7000, Belgium

Location

MeSH Terms

Conditions

Muscular Dystrophy, Facioscapulohumeral

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Alexandre Legrand (PhD, MD, principal investigator)

    University of Mons

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Dean of the Faculty of Medicine and Pharmacy

Study Record Dates

First Submitted

May 17, 2024

First Posted

May 22, 2024

Study Start

May 14, 2024

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

BE(1)