Primary Disease Fascioscapulohumeral Dystrophy (FSHD)FSHDNCT02622438
Routine Health Care of Patients With FSHD
A study testing Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient. in people with Primary Disease Fascioscapulohumeral Dystrophy (FSHD), run by University Hospital, Montpellier at 1 site in France.
Trial summary
On the basis of published data and our results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators conducted a pilot randomized double-blind placebo controlled trial to test whether oral administration of vitamins and mineral could improve… Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Primary Disease Fascioscapulohumeral Dystrophy (FSHD)
- What is being tested?
- Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2015to 3 Jul 2024
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Molecular and clinical diagnosis for FSHD
- patients, men and women aged > 7 years,
Who cannot join
- pregnant women
- Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
- Major protected by law (guardianship, curatorship or under judicial protection)
Trial locations and contacts
1 site in 1 country.
France1 site
Montpellier University Hospital- Saint Eloi Hospital
Montpellier, Languedoc-Roussillon, 34294
About this study
Official title: Course and Follow up of Patients Affected by Facioscapulohumeral Muscular Dystrophy
On the basis of published data and our results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators conducted a pilot randomized double-blind placebo controlled trial to test whether oral administration of vitamins and mineral could improve the physical performance of patients with FSHD.The result of this clinical trial showed that antioxidants supplementation may improve skeletal muscle function of patients with FSHD and suggest that an antioxidant strategy adapted may be a relevant therapeutic approach for these patients. Since then, patients with FSHD who attend consultation at Montpellier hospital are systematically supplemented with antioxidants according their own blood tests.
Read the detailed description
This study will assess course of patients with FSHD in accordance with usual care performed within the Department of clinical physiology at the University hospital of Montpellier. This prospective longitudinal study include an initial assessment. Then the follow up of patients will be monitored at 12 months and annually. The eventual objective will be to develop a FSHD disease cohort in care at the Montpellier hospital. A statistical analysis will be performed at 3-years follow-up
- Being tested
- Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient.
- Keywords
- FSHD, Usual care performed at Montpellier hospital, Muscle function, Antioxidants, Oxidative stress, Quality of life, Physical activities, development of food-based dietary guidelines, Co-morbidity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient.Other
| Study group | Role | What they receive |
|---|---|---|
| Course and follow up of patients affected by FSHD | Other | Not described Receives: Other: Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Measured: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Measured: 12 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Measured: 24 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Measured: 36 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Measured: 48 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Measured: 60 months after inclusion
Secondary outcomes (18)
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Measured: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Measured: 12 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Measured: 24 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Measured: 36 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Measured: 48 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Measured: 60 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Measured: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on physical activities (Vorrips questionnaire)
Measured: 12 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Measured: 24 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Measured: 36 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Measured: 48 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Measured: 60 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Measured: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Measured: 12 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Measured: 24 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Measured: 36 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Measured: 48 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Measured: 60 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start19 Apr 2015
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Disease Fascioscapulohumeral Dystrophy (FSHD)Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques MERCIER, MD PhD, Principal investigator, CHRU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622438
- Sponsor's protocol ID
- 9371
- Acronym
- FSHD
- Status last verified
- Feb 2025
- First submitted
- 30 Nov 2015
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Course and Follow up of Patients Affected by Facioscapulohumeral Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT02622438
- Acronym / sponsor ID
- FSHD / 9371
- Keywords
- FSHD, Usual care performed at Montpellier hospital, Muscle function, Antioxidants, Oxidative stress, Quality of life, Physical activities, development of food-based dietary guidelines, Co-morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Apr 2015 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 4 Dec 2015 (estimated)
- 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.
On the basis of published data and our results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators conducted a pilot randomized double-blind placebo controlled trial to test whether oral administration of vitamins and mineral could improve the physical performance of patients with FSHD.The result of this clinical trial showed that antioxidants supplementation may improve skeletal muscle function of patients with FSHD and suggest that an antioxidant strategy adapted may be a relevant therapeutic approach for these patients. Since then, patients with FSHD who attend consultation at Montpellier hospital are systematically supplemented with antioxidants according their own blood tests.
Detailed description
This study will assess course of patients with FSHD in accordance with usual care performed within the Department of clinical physiology at the University hospital of Montpellier. This prospective longitudinal study include an initial assessment. Then the follow up of patients will be monitored at 12 months and annually. The eventual objective will be to develop a FSHD disease cohort in care at the Montpellier hospital. A statistical analysis will be performed at 3-years follow-up
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Course and follow up of patients affected by FSHD | Other | Other: Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Molecular and clinical diagnosis for FSHD
- patients, men and women aged > 7 years,
Key exclusion criteria (3 listed)
- pregnant women
- Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
- Major protected by law (guardianship, curatorship or under judicial protection)
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 |
|---|---|---|
| Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient. | Other | Course and follow up of patients affected by FSHD |
Primary outcome
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 12 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 24 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 36 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 48 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 60 months after inclusion
18 secondary outcomes
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 12 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 24 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 36 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 48 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 60 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Time frame: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on physical activities (Vorrips questionnaire)
Time frame: 12 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Time frame: 24 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Time frame: 36 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Time frame: 48 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Time frame: 60 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 12 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 24 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 36 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 48 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 60 months after inclusion
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 21 Feb 2025.
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Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
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.
Jacques MERCIER, MD PhD principal investigator
CHRU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient. in people with Primary Disease Fascioscapulohumeral Dystrophy (FSHD), run by University Hospital, Montpellier at 1 site in France.
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 2 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 21 Feb 2025. 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 France. 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?
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg (time frame: 1 day (the day of inclusion)). The study lists 6 primary outcomes in all. 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 21 Feb 2025.