Trial Outcomes & Findings for DART Electrical Impedance Myography (EIM) Trial in Duchenne Muscular Dystrophy (DMD) and Healthy Controls (NCT NCT01523964)
NCT ID: NCT01523964
Last Updated: 2013-12-09
Results Overview
Adverse events will be assessed during the time the subject is enrolled in the trial.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
1 day
Results posted on
2013-12-09
Participant Flow
Recruitment was from February 2012 to August 2013. Subjects know to the site staff were approached during clinic visits or by telephone to ascertain interest. In addition, referrals from message posted on DMD website were included if they met protocol criteria.
There were no significant events. Subjects were screened for eligibility and enrolled.
Participant milestones
| Measure |
DMD Subject Ages 3-7 Inclusive
|
DMD Subject Ages 8-12 Inclusive
|
Healthy Control Ages 3-7 Inclusive
|
Healthy Control Ages 8-12 Inclusive
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
16
|
15
|
|
Overall Study
COMPLETED
|
31
|
30
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DART Electrical Impedance Myography (EIM) Trial in Duchenne Muscular Dystrophy (DMD) and Healthy Controls
Baseline characteristics by cohort
| Measure |
DMD Subject Ages 3-7 Inclusive
n=31 Participants
|
DMD Subject Ages 8-12 Inclusive
n=30 Participants
|
Healthy Control Ages 3-7 Inclusive
n=16 Participants
|
Healthy Control Ages 8-12 Inclusive
n=15 Participants
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
16 participants
n=5 Participants
|
15 participants
n=4 Participants
|
92 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 dayAdverse events will be assessed during the time the subject is enrolled in the trial.
Outcome measures
| Measure |
DMD Subject Ages 3-7 Inclusive
n=31 Participants
|
DMD Subject Ages 8-12 Inclusive
n=30 Participants
|
Healthy Control Ages 3-7 Inclusive
n=16 Participants
|
Healthy Control Ages 8-12 Inclusive
n=15 Participants
|
|---|---|---|---|---|
|
Number of Subjects With an Adverse Event.
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Healthy Control Ages 8-12 Inclusive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DMD Subject Ages 3-7 Inclusive
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DMD Subject Ages 8-12 Inclusive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Control Ages 3-7 Inclusive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Control Ages 8-12 Inclusive
n=15 participants at risk
|
DMD Subject Ages 3-7 Inclusive
n=31 participants at risk
|
DMD Subject Ages 8-12 Inclusive
n=30 participants at risk
|
Healthy Control Ages 3-7 Inclusive
n=16 participants at risk
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
scab on left ankle abrasion dislodged
|
0.00%
0/15 • 1 day (length of subject participation)
|
3.2%
1/31 • Number of events 1 • 1 day (length of subject participation)
|
0.00%
0/30 • 1 day (length of subject participation)
|
0.00%
0/16 • 1 day (length of subject participation)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60