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:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT02530905
Eligibility Criteria:
Inclusion Criteria:
* Genotypically confirmed DMD (amenable to exon 45 skipping).
* Stable cardiac and pulmonary function.
* Limited or no ambulation.
* On a stable dose of oral corticosteroids for at least 24 weeks OR has not received corticosteroids for at least 24 weeks.
Exclusion Criteria:
* Current or previous treatment with the experimental agents SMT C1100 (BMN-195) or PRO045.
* Other experimental treatment in the past 12 weeks.
* If on cardiac medication, must be on a stable dose for the past 12 weeks.
* Major surgery within the past 3 months.
Other inclusion/exclusion criteria apply.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
7 Years
Maximum Age:
21 Years
Study:
NCT02530905
Study Brief:
Protocol Section:
NCT02530905