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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT01856868
Eligibility Criteria:
Inclusion Criteria:
* Male
* Age 18 years to 60 years
* Average to low daily physical activity
* Ability to ambulate for 75 meters without assistive devices
* Diagnosis of BMD confirmed by at least one the following:
* Dystrophin immunofluorescence and/or immunoblot showing partial dystrophin deficiency, and clinical picture consistent with typical BMD, or
* Gene deletions test positive (missing one or more exons) of the dystrophin gene, where reading frame can be predicted as 'in-frame', and clinical picture consistent with typical BMD, or
* Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) that can be definitely associated with BMD, with a typical clinical picture of BMD, or
* Positive family history of BMD confirmed by one of the criteria listed above in a sibling or maternal uncle, and clinical picture typical of BMD.
* Nutritional, herbal and antioxidant supplements taken with the intent of maintaining or improving skeletal muscle strength or functional mobility have been discontinued at least 2 weeks prior to screening (daily multivitamin use is acceptable).
* Hematology profile within normal range
* Baseline laboratory safety chemistry profile within normal range
* No plan to change exercise regimen during study participation
Exclusion Criteria:
* Currently enrolled in another treatment clinical trial.
* History of significant concomitant illness or significant impairment of renal or hepatic function.
* Use of regular daily aspirin or other medication with antiplatelet effects within 3 weeks of first dose of study medication.
* Regular participation in vigorous exercise.
* Symptomatic heart failure with cardiac ejection fraction \<25%
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01856868
Study Brief:
Protocol Section:
NCT01856868