Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT04668716
Eligibility Criteria:
Inclusion Criteria:
For DMD patients:
* Male
* age 5-17 years
* genetically-proven diagnosis of DMD
* genetic mutation that abrogates expression of Dp427 alone (assigned in DMD Group 1: Dp427-/Dp140+) or both Dp427 and Dp140 (assigned to DMD Group 2: Dp427-/Dp140-); or all isoforms (assigned to DMD group 3)
For BMD patients:
* age 5-50 years
* genetically-proven diagnosis of BMD
* genetic mutation that decreases expression of Dp427 alone (assigned to BMD Group 1), of both Dp427 and Dp140 (assigned to BMD Group 2), or of all the isoforms (assigned to BMD group 3).
For MRI controls:
* Male
* age 5-50 years
Exclusion Criteria:
For DMD and BMD patients:
* Lack of a molecular diagnosis of DMD or BMD
* Mutation falls outside the regions of interest
* A severe co-morbidity or planned surgical intervention within 6 months from the study which could interfere with the well-being of the participant
For MRI controls:
* any muscle disease
* a brain disorder (such as severe brain concussion in past history, congenital brain anomalies, epilepsy)
General exclusion criteria for MRI:
* Claustrophobia
* Pacemakers and defibrillators
* Nerve stimulators
* Intracranial clips
* Intraorbital or intraocular metallic fragments
* Cochlear implants
* Ferromagnetic implants (e.g. thoracic implant for scoliosis)
* Inability to lie supine during less than 45 minutes
* not having a general practitioner
* severe learning disability which will require a general anaesthetic
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
5 Years
Maximum Age:
50 Years
Study:
NCT04668716
Study Brief:
Protocol Section:
NCT04668716