NCT04349566

Brief Summary

The purpose of the study is to explore the biomarker Fast Troponins response to exercise in patients with Becker muscular dystrophy, Limb-girdle muscular dystrophy and McArdle disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

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

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

April 14, 2020

Last Update Submit

October 26, 2022

Conditions

Becker Muscular DystrophyMcArdle DiseaseLimb-Girdle Muscular Dystrophy Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in biomarkers

    Change in Fast and slow Troponin I after muscle damage

    24 hours

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with McArdle disease and patients with two sub-typesof Limb-girdle and Becker muscular dystrophies will be included as well as healthy controls.

You may qualify if:

  • The ability to cycle
  • No concurrent medical condition that could interfere with interpretation of the results
  • Molecular diagnosis of the specific condition in specified patient groups or healthy control
  • No active muscle injury on the test day (caused by recent exercise, seizures, trauma, etc.)

You may not qualify if:

  • Competing conditions at risk of compromising the results of the study
  • Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise
  • Veins that are too difficult to puncture for blood sampling, evaluated by the investigator
  • Severe muscle weakness, that prevents the subject completing the exercise test, evaluated by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromuscular Research Unit, 3342

Copenhagen, DK-2100, Denmark

Location

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneGlycogen Storage Disease Type VLimb-girdle muscular dystrophy type 2A

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGlycogen Storage DiseaseCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 16, 2020

Study Start

June 1, 2020

Primary Completion

December 20, 2021

Study Completion

December 20, 2021

Last Updated

October 27, 2022

Record last verified: 2022-10

Locations

DK(1)