NCT02159612

Brief Summary

An investigation of disease progression in adult danish patients with facioscapulohumeral muscular dystrophy. The disease progression is followed for a year with two test-days, including functional muscle tests and a MRI scan of muscles in the back and legs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

June 6, 2014

Last Update Submit

May 13, 2015

Conditions

FSHD - Facioscapulohumeral Muscular Dystrophy

Keywords

FSHDMRIDisease progression

Outcome Measures

Primary Outcomes (1)

  • Fat infiltration

    Change in the distribution of fat infiltration in back, thigh and calves muscles seen at the MRI images.

    1 year

Secondary Outcomes (4)

  • Muscle structure

    1 year

  • Muscle strength

    1 year

  • Back pain

    1 year

  • Muscle function

    1 year

Study Arms (1)

FSHD

A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan.

Other: MRI

Interventions

MRIOTHER

MRI scan of muscles in the back and legs. Including T1, DIXON and STIR images.

FSHD

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons in Denmark diagnosed with Facioscapulohumeral muscular dystrophy is invited to the study.

You may qualify if:

  • Diagnosed with FSHD type 1

You may not qualify if:

  • Pregnant or breastfeeding women.
  • Patients with claustrophobia.
  • Patients with implanted metallic parts in the body.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromuscular Research Unit, Department of Neurology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Dahlqvist JR, Poulsen NS, Ostergaard ST, Fornander F, de Stricker Borch J, Danielsen ER, Thomsen C, Vissing J. Evaluation of inflammatory lesions over 2 years in facioscapulohumeral muscular dystrophy. Neurology. 2020 Sep 1;95(9):e1211-e1221. doi: 10.1212/WNL.0000000000010155. Epub 2020 Jul 1.

    PMID: 32611642DERIVED

Related Links

MeSH Terms

Conditions

Muscular Dystrophy, FacioscapulohumeralDisease Progression

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 10, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

DK(1)