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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT01978366
Eligibility Criteria:
Inclusion Criteria:
* Completed both the single ascending dose (SAD) and multiple ascending dose (MAD) phases of predecessor study HALO-DMD-01
* Maintained the same corticosteroid therapy from the predecessor study HALO-DMD-01
* Ability to provide written informed consent
* Ambulatory or non-ambulatory
Exclusion Criteria:
* Recent, substantial change in use of cardiac medications or medications affecting muscle function
* Clinically significant major disease, not related to DMD
* Significantly compromised cardio-respiratory function
* History of severe allergic or anaphylactic reactions
* Prior treatment with another investigational product in past 6 months
* Inability to undergo magnetic resonance imaging (MRI)
* Current drug or alcohol abuse or prior treatment for abuse
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
6 Years
Maximum Age:
20 Years
Study:
NCT01978366
Study Brief:
Protocol Section:
NCT01978366