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 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT02310906
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with DMD, genotypically confirmed.
* Intact right and left biceps muscles or an alternative upper arm muscle group.
* Stable pulmonary and cardiac function.
* Minimum performance on 6MWT, North Star Ambulatory Assessment, and rise (Gowers) test as specified in the study protocol.
* On a stable dose of corticosteroids for at least 6 months.
Exclusion Criteria:
* Previous treatment with the experimental agents BMN-195 (SMT C1100) or PRO053.
* Current or previous treatment with any other experimental treatments within 12 weeks prior to study entry.
* Major surgery within the last 3 months.
* Presence of other clinically significant illness.
* Major change in physical therapy regime within the last 3 months.
Other inclusion and exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
6 Years
Maximum Age:
15 Years
Study:
NCT02310906
Study Brief:
Protocol Section:
NCT02310906