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:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT01153932
Eligibility Criteria:
Inclusion Criteria:
* Ambulant subjects with Duchenne muscular dystrophy resulting from a mutation in the DMD gene, confirmed by a state-of-the-art DNA diagnostic technique covering all DMD gene exons, including but not limited to MLPA (Multiplex Ligation-dependent Probe Amplification), CGH (Comparative Genomic Hybridisation) or H-RMCA (High-Resolution Melting Curve Analysis), and correctable by GSK2402968-induced DMD exon 51 skipping,
* Males, at least 5 years of age and with a life expectancy of at least 1 year
* Able to rise from floor in ≤7 seconds (without aids/orthoses),
* Able to complete the 6MWD test with a distance of at least 75m
* Receiving glucocorticoids for a minimum of 6 months immediately prior to screening, with no significant change in total daily dosage or dosing regimen for a minimum of 3 months immediately prior to screening and a reasonable expectation that total daily dosage and dosing regimen will not change significantly for the duration of the study
* QTc \<450msec
* On adequate contraception
* Able to comply with and complete all protocol requirements
Exclusion Criteria:
* any additional missing exon for DMD
* Current of history of liver or renal disease or impairment
* Acute illness within 4 weeks of the first dose
* Use of prohibited meds within 6 months of fist dose
* Current participation in any other investigational clinical trial
* Positive hepatitis B surface antigen, hepatitis C antibody test, or human immunodeficiency virus (HIV) test at screening
* Symptomatic cardiomyopathy
* Children in Care
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
5 Years
Study:
NCT01153932
Study Brief:
Protocol Section:
NCT01153932