MRI in McArdle Disease (GSDV)

Glycogen Storage Disease Type V Clinical Trial

Official title:

MRI in McArdle Disease (Glycogen Storage Disease Type V)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844022
• Other study ID #: H-18023049.1
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to describe the degree of muscle wasting in patients with McArdle disease judged by MRI, quantitative magnetic resonance (DIXON) and T1 weighted images, and muscle strength, collected across multiple European sites and compared to healthy controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• GSDV or healthy controls

Exclusion Criteria:

• MRI contradictions

Related Conditions & MeSH terms

• Disease
• Glycogen Storage Disease
• Glycogen Storage Disease Type V

Intervention

Diagnostic Test:
• MRI
magnetic resonance imaging

Locations

Country	Name	City	State
Denmark	Copenhagen Neuromuscular Center, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DIXON MRI	Whole body quantitative muscle fat fraction analyses (DIXON)	1 time
Secondary	Muscle strength	MRC scale	1 time
Secondary	T1 MRI	Whole body qualitative muscle fat fraction analyses (T1)	1 time
Secondary	Back pain questionnaire	Back pain questionnaire	1 time