Status:
COMPLETED
DART Electrical Impedance Myography (EIM) Trial in Duchenne Muscular Dystrophy (DMD) and Healthy Controls
Lead Sponsor:
Dart Therapeutics. LLC
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
3-12 years
Phase:
NA
Brief Summary
Physicians seek a method to assess neuromuscular disease that is both non-invasive and quantifiable. Many patients do not tolerate standard current day assessment tools (such as needle electromyogram)...
Detailed Description
Healthy subjects and subjects with DMD will be screened during Visit 1. Screening evaluations will establish eligibility and will include a medical history, abbreviated physical examination, vital sig...
Eligibility Criteria
Inclusion
- DMD Subject Cohorts
- Male subjects
- Subjects with a chronologic age of 3 to 7 years inclusive for Cohort A, and 8 to 12 years inclusive for Cohort B
- Subjects with DMD diagnosed with mutational testing and/or absence of dystrophin on muscle biopsy
- Subjects with proximal pelvic girdle weakness (Gower's maneuver, difficulty with arising from floor and going up steps)
- Subjects who can walk 10 meters unassisted (ie, without braces, canes, or other aids)
- Subjects who are taking systemic corticosteroids and/or any other medication which, in the judgment of the investigator, could impact muscle strength or physical activity levels, must be on a stable dose for at least 4 weeks prior to initiation of study measurements
- Subjects who provide assent, as stipulated by IRB requirements, and whose parent/guardian signs an informed consent form
- Subjects who are willing and able to cooperate and comply with all protocol requirements and procedures
- Healthy Control Cohort
- Healthy males with normal neuromuscular examination
- Subjects with a chronologic age of 3 to 7 years inclusive for Cohort C, and 8 to 12 years inclusive for Cohort D
- Subjects who provide assent, as stipulated by IRB requirements, and whose parent/guardian signs an informed consent form
- Subjects who are willing and able to cooperate and comply with all protocol requirements and procedures
Exclusion
- Subjects with daytime ventilatory dependence (non-invasive or tracheostomy)
- Subjects enrolled in a DMD therapeutic clinical trial concomitantly or within the past 4 weeks
- Subjects with any physical or mental condition which may, in the investigator's opinion, render the subject unable to complete the tasks of the study appropriately
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01523964
Start Date
February 1 2012
End Date
August 1 2012
Last Update
December 9 2013
Active Locations (6)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Massauchusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Washington University
St Louis, Missouri, United States, 63110
4
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229