Facioscapulohumeral Muscular Dystrophy 1aNCT02541292
Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD
An observational study of Facioscapulohumeral Muscular Dystrophy 1a, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy with approximately 500 patients in Denmark. It is characterized by weakness and wasting of the facial muscles, the muscles in the shoulder region and of the legs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facioscapulohumeral Muscular Dystrophy 1a
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Nov 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons in Denmark diagnosed with FSHD is invited to the study.
Who may be able to join
- Confirmed FSHD
Who cannot join
- All contraindications for undergoing an MRI scan
Trial locations and contacts
1 site in 1 country.
About this study
Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy with approximately 500 patients in Denmark. It is characterized by weakness and wasting of the facial muscles, the muscles in the shoulder region and of the legs.
The primary aim of this study is to investigate possible links and order between inflammation and fat infiltration in the muscles in patients with FSHD.
Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year where the inflammation and fat infiltration in the muscles can be quantified.
- Being tested
- No intervention, observational
- Medical subject headings
- Facioscapulohumeral muscular dystrophy 1a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observationalOther
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Patients over 18 years old with confirmed FSHD (facioscapulohumeral muscular dystrophy). Receives: Other: No intervention, observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle inflammation
MRI (t2 mapping) will be used to quantify the inflammation in skeletal muscle.
Measured: One MRI scan per subject (exam lasts approximately 60 min.)
Muscle fat fraction
The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.
Measured: One MRI scan per subject (exam lasts approximately 60 min.)
Secondary outcomes (1)
Muscle strength
Isokinetic muscle dynamometry will be used to measure muscle strength.
Measured: One muscle strength test per subject (exam lasts approximately 60 min.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startFeb 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facioscapulohumeral Muscular Dystrophy 1aStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Dahlqvist, MD, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541292
- Sponsor's protocol ID
- H-15009760
- Status last verified
- Aug 2018
- First submitted
- 2 Sep 2015
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD
- ClinicalTrials.gov ID
- NCT02541292
- Acronym / sponsor ID
- H-15009760
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 4 Sep 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.
Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy with approximately 500 patients in Denmark. It is characterized by weakness and wasting of the facial muscles, the muscles in the shoulder region and of the legs.
The primary aim of this study is to investigate possible links and order between inflammation and fat infiltration in the muscles in patients with FSHD.
Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year where the inflammation and fat infiltration in the muscles can be quantified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Other: No intervention, observationalPatients over 18 years old with confirmed FSHD (facioscapulohumeral muscular dystrophy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons in Denmark diagnosed with FSHD is invited to the study.
Key inclusion criteria (1 listed)
- Confirmed FSHD
Key exclusion criteria (1 listed)
- All contraindications for undergoing an MRI scan
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 |
|---|---|---|
| No intervention, observational | Other | Patient group |
Primary outcome
Muscle inflammation
Time frame: One MRI scan per subject (exam lasts approximately 60 min.)
MRI (t2 mapping) will be used to quantify the inflammation in skeletal muscle.
Muscle fat fraction
Time frame: One MRI scan per subject (exam lasts approximately 60 min.)
The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.
1 secondary outcome
Muscle strength
Time frame: One muscle strength test per subject (exam lasts approximately 60 min.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
Related trials for Facioscapulohumeral Muscular Dystrophy 1a
RecruitingPhase 1/2
A Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of SFL-0821 in Adults With FSHD
Facioscapulohumeral Muscular Dystrophy (FSHD)
RecruitingObservational study
Biomarker Development for Muscular Dystrophies
Myotonic Dystrophy, Duchenne Muscular Dystrophy
RecruitingPhase 1
Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)
FSHD - Facioscapulohumeral Muscular Dystrophy
Not yet recruitingPhase 2
A Study of SAT-3247 to Evaluate the Safety, Tolerability, and Efficacy in Participants With Facioscapulohumeral Muscular Dystrophy (FSHD)
Facioscapulohumeral Muscular Dystrophy (FSHD)
Enrolling by invitationPhase 1/2
Study of SRP-1001 in Adult and Adolescent Participants With Facioscapulohumeral Muscular Dystrophy Type 1
Muscular Dystrophy, Facioscapulohumeral
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facioscapulohumeral Muscular Dystrophy 1a, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Sep 2018. 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 Denmark. 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?
Results are not available in the source record.
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?
Muscle inflammation (time frame: One MRI scan per subject (exam lasts approximately 60 min.)). The study lists 2 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 4 Sep 2018.