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DART Electrical Impedance Myography (EIM) Trial in Duchenne Muscular Dystrophy (DMD) and Healthy Controls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01523964
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Dart Therapeutics. LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Duchenne Muscular Dystrophy
Intervention Other: Testing with EIM
Enrollment 92
Recruitment Details 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.
Pre-assignment Details There were no significant events. Subjects were screened for eligibility and enrolled.
Arm/Group Title DMD Subject Ages 3-7 Inclusive DMD Subject Ages 8-12 Inclusive Healthy Control Ages 3-7 Inclusive Healthy Control Ages 8-12 Inclusive
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 31 30 16 15
Completed 31 30 16 15
Not Completed 0 0 0 0
Arm/Group Title DMD Subject Ages 3-7 Inclusive DMD Subject Ages 8-12 Inclusive Healthy Control Ages 3-7 Inclusive Healthy Control Ages 8-12 Inclusive Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 31 30 16 15 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 30 participants 16 participants 15 participants 92 participants
<=18 years
31
 100.0%
30
 100.0%
16
 100.0%
15
 100.0%
92
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 30 participants 16 participants 15 participants 92 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
31
 100.0%
30
 100.0%
16
 100.0%
15
 100.0%
92
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 30 participants 16 participants 15 participants 92 participants
31 30 16 15 92
1.Primary Outcome
Title Number of Subjects With an Adverse Event.
Hide Description Adverse events will be assessed during the time the subject is enrolled in the trial.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DMD Subject Ages 3-7 Inclusive DMD Subject Ages 8-12 Inclusive Healthy Control Ages 3-7 Inclusive Healthy Control Ages 8-12 Inclusive
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 30 16 15
Measure Type: Number
Unit of Measure: participants
1 0 0 0
Time Frame 1 day (length of subject participation)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DMD Subject Ages 3-7 Inclusive DMD Subject Ages 8-12 Inclusive Healthy Control Ages 3-7 Inclusive Healthy Control Ages 8-12 Inclusive
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
DMD Subject Ages 3-7 Inclusive DMD Subject Ages 8-12 Inclusive Healthy Control Ages 3-7 Inclusive Healthy Control Ages 8-12 Inclusive
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DMD Subject Ages 3-7 Inclusive DMD Subject Ages 8-12 Inclusive Healthy Control Ages 3-7 Inclusive Healthy Control Ages 8-12 Inclusive
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/30 (0.00%)      0/16 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DMD Subject Ages 3-7 Inclusive DMD Subject Ages 8-12 Inclusive Healthy Control Ages 3-7 Inclusive Healthy Control Ages 8-12 Inclusive
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/31 (3.23%)      0/30 (0.00%)      0/16 (0.00%)      0/15 (0.00%)    
Skin and subcutaneous tissue disorders         
scab on left ankle abrasion dislodged  [1]  1/31 (3.23%)  1 0/30 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Subject has prior left ankle abrasion with scab. During 6 minute walk scab was dislodged during a fall.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Operating Officer
Organization: DART Therapeutics
Phone: 415-341-5783
Responsible Party: Dart Therapeutics. LLC
ClinicalTrials.gov Identifier: NCT01523964     History of Changes
Other Study ID Numbers: CMD-001
First Submitted: January 30, 2012
First Posted: February 1, 2012
Results First Submitted: August 9, 2013
Results First Posted: December 9, 2013
Last Update Posted: December 9, 2013