Becker Muscular DystrophyNCT04349566
Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases
An observational study of Becker Muscular Dystrophy and McArdle Disease, run by Mads Peter Godtfeldt Stemmerik at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Becker Muscular Dystrophy, McArdle Disease, Limb-Girdle Muscular Dystrophy Type 2
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 20 Dec 2021
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Muscular Dystrophy, Duchenne, Glycogen Storage Disease Type V, Limb-girdle muscular dystrophy type 2A
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarkers
Change in Fast and slow Troponin I after muscle damage
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Jun 2020
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Becker Muscular DystrophyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mads Peter Godtfeldt Stemmerik
- Sponsor type
- University, hospital or other
- Collaborators
- Edgewise Therapeutics, Inc.
- Responsible party
- Sponsor-investigator, Mads Peter Godtfeldt Stemmerik, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349566
- Sponsor's protocol ID
- FAST TROPONIN
- Status last verified
- Oct 2022
- First submitted
- 14 Apr 2020
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases
- ClinicalTrials.gov ID
- NCT04349566
- Acronym / sponsor ID
- FAST TROPONIN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mads Peter Godtfeldt StemmerikUniversity, hospital or other
- Collaborators
- Edgewise Therapeutics, Inc.
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 16 Apr 2020 (actual)
- 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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in biomarkers
Time frame: 24 hours
Change in Fast and slow Troponin I after muscle damage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
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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 Becker Muscular Dystrophy and McArdle Disease, run by Mads Peter Godtfeldt Stemmerik 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 27 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in biomarkers (time frame: 24 hours). 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 27 Oct 2022.