NCT02541292

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

September 2, 2015

Last Update Submit

August 31, 2018

Conditions

Facioscapulohumeral Muscular Dystrophy 1a

Outcome Measures

Primary Outcomes (2)

  • Muscle inflammation

    MRI (t2 mapping) will be used to quantify the inflammation in skeletal muscle.

    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.

    One MRI scan per subject (exam lasts approximately 60 min.)

Secondary Outcomes (1)

  • Muscle strength

    One muscle strength test per subject (exam lasts approximately 60 min.)

Study Arms (1)

Patient group

Patients over 18 years old with confirmed FSHD (facioscapulohumeral muscular dystrophy).

Other: No intervention, observational

Interventions

No intervention, observationalOTHER
Patient group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons in Denmark diagnosed with FSHD is invited to the study.

You may qualify if:

  • Confirmed FSHD

You may not qualify if:

  • All contraindications for undergoing an MRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Neuromuscular Center

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Facioscapulohumeral muscular dystrophy 1a

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 4, 2015

Study Start

February 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

September 4, 2018

Record last verified: 2018-08

Locations

DK(1)