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Trial record 59 of 1004 for:    BMD

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

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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

Tracking Information
First Submitted Date  ICMJE January 30, 2012
First Posted Date  ICMJE February 1, 2012
Results First Submitted Date  ICMJE August 9, 2013
Results First Posted Date  ICMJE December 9, 2013
Last Update Posted Date December 9, 2013
Study Start Date  ICMJE February 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2013)
Number of Subjects With an Adverse Event. [ Time Frame: 1 day ]
Adverse events will be assessed during the time the subject is enrolled in the trial.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01523964 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DART Electrical Impedance Myography (EIM) Trial in Duchenne Muscular Dystrophy (DMD) and Healthy Controls
Official Title  ICMJE A Phase I, Multi-Center, Controlled, Prospective Correlative Study of Electrical Impedance Myography in Males With Duchenne Muscular Dystrophy and In Healthy Males
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), and Electrical Impedance Myography (EIM) has the potential to serve as a non-invasive, quantifiable, diagnostic tool for neuromuscular disease. If successful, these devices will allow for improved ability to diagnose neuromuscular disease and to assess disease progression or remission, allowing for better care of individual patients as well as for use in clinical trials, where improved outcome measures for neuromuscular diseases is being sought.
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 signs (blood pressure, temperature, pulse, and respirations), and weight. Eligible subjects will provide assent, as stipulated by Institutional Review Board (IRB) requirements, and a parent/guardian will sign an informed consent, after which the subject will be considered enrolled.

Subjects will be enrolled into 4 study cohorts for a total of approximately 90 subjects. Allocation into these cohorts is planned due to considerations regarding the effect of age on outcomes.

Visit 2, Study Assessments, may take place on the day of Visit 1 screening evaluations. If the subject cannot complete study assessments on the same day, the subject may return and complete Visit 2 evaluations within approximately 24 hours of the end of Visit 1.

Visit 2 assessments will include morphological testing of muscle length and girth, skin fat measurement, Clinical Assessments (6-Minute Walk Test [6MWT], North Star Ambulatory Assessment, timed function tests, dynamometry), and 3 phases of Device Performance testing. Phase 1 Device Performance testing will be done by each of 2 trained raters (Rater A and Rater B) from the research site, designated to perform the Device Performance testing on all subjects at their respective site. At least 10 minutes after completion of the first assessments, Phase 2 Device Performance testing will be repeated by Rater A. Upon completion of the Phase 2 Device Performance testing, the subjects will proceed with Clinical Assessments performed by a physical therapist. Following Clinical Assessments, Phase 3 Device Performance testing will be performed by Rater B.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Duchenne Muscular Dystrophy
Intervention  ICMJE Other: Testing with EIM
Study Arms  ICMJE
  • DMD subject ages 3-7 inclusive
    Young DMD Testing with EIM
    Intervention: Other: Testing with EIM
  • DMD subject ages 8-12 inclusive
    Older DMD Testing with EIM
    Intervention: Other: Testing with EIM
  • Healthy Control ages 3-7 inclusive
    Young Healthy Testing with EIM
    Intervention: Other: Testing with EIM
  • Healthy Control ages 8-12 inclusive
    Older Healthy Testing with EIM
    Intervention: Other: Testing with EIM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2013)
92
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2012)
90
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01523964
Other Study ID Numbers  ICMJE CMD-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dart Therapeutics. LLC
Study Sponsor  ICMJE Dart Therapeutics. LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dart Therapeutics. LLC
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP