Facioscapulohumeral Muscular DystrophyNCT06425445
Quantitative Assessment of Orofacial Muscle Function in FSHD
A study testing Orofacial function assessment tests in people with Facioscapulohumeral Muscular Dystrophy, run by University of Mons at 1 site in Belgium.
Trial summary
The goal of this study is to validate a new method for the assessment of orofacial muscles in FSHD affected individuals Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facioscapulohumeral Muscular Dystrophy
- What is being tested?
- Orofacial function assessment tests
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 14 May 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Genetic diagnosis of FSHD type 1 and/or type 2
Who cannot join
- Pregnant women
- Presence of other associated neuromuscular conditions
- Any unstable interfering clinical situation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a New Clinical Tool for the Assessment of Orofacial Muscles in Patients Affected by Facioscapulohumeral Muscular Dystrophy: a Preliminary Study.
The goal of this study is to validate a new method for the assessment of orofacial muscles in FSHD affected individuals
- Conditions
- Facioscapulohumeral Muscular Dystrophy
- Being tested
- Orofacial function assessment tests
- Medical subject headings
- Muscular Dystrophy, Facioscapulohumeral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orofacial function assessment testsProcedure or surgery
Participants undergo serial measurements for the assessment of orofacial function
| Study group | Role | What they receive |
|---|---|---|
| Affected participants | Experimental | Not described Receives: Procedure: Orofacial function assessment tests |
| Healthy participants | Experimental | Not described Receives: Procedure: Orofacial function assessment tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
A performance index based on serial assessments of each participant
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start14 May 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facioscapulohumeral Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mons
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Legrand, University of Mons
- Investigators
- Alexandre Legrand (PhD, MD, principal investigator), Principal investigator, University of Mons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425445
- Sponsor's protocol ID
- P2024/031
- Status last verified
- Feb 2026
- First submitted
- 17 May 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Clinical Tool for the Assessment of Orofacial Muscles in Patients Affected by Facioscapulohumeral Muscular Dystrophy: a Preliminary Study.
- ClinicalTrials.gov ID
- NCT06425445
- Acronym / sponsor ID
- P2024/031
- Conditions
- Facioscapulohumeral Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MonsUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to validate a new method for the assessment of orofacial muscles in FSHD affected individuals
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected participants | Experimental | Procedure: Orofacial function assessment tests |
| Healthy participants | Experimental | Procedure: Orofacial function assessment tests |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Genetic diagnosis of FSHD type 1 and/or type 2
Key exclusion criteria (3 listed)
- Pregnant women
- Presence of other associated neuromuscular conditions
- Any unstable interfering clinical situation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orofacial function assessment testsParticipants undergo serial measurements for the assessment of orofacial function | Procedure or surgery | Affected participants, Healthy participants |
Primary outcome
A performance index based on serial assessments of each participant
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Legrand (PhD, MD, principal investigator) principal investigator
University of Mons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orofacial function assessment tests in people with Facioscapulohumeral Muscular Dystrophy, run by University of Mons at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A performance index based on serial assessments of each participant (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.