A Low Interventional Study to Monitor Activity Using Wearable Sensors in Duchenne Muscular Dystrophy
NCT ID: NCT04254172
Last Updated: 2021-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2 participants
OBSERVATIONAL
2020-02-19
2020-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Single cohort
There is no randomization or stratification in this study. All subjects will complete the same study assessments.
Activity Monitor
Wrist and ankle sensors to be worn continuously for 2-week intervals.
Interventions
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Activity Monitor
Wrist and ankle sensors to be worn continuously for 2-week intervals.
Eligibility Criteria
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Inclusion Criteria
* Body weight between 15 and 50 kg
* Receipt of glucocorticoids for 6 months and a stable daily dose for at least 3 months prior to study entry
* Ability to rise from floor within seven (7) seconds and ability to walk
Exclusion Criteria
* Prior exposure to any gene therapy agent, including exon-skipping and missense agents.
* Exposure to other investigational drugs within 30 days or 5 half-lives, whichever is longer.
* Any injury which may impact functional testing per investigator's judgement. Previous injuries must be fully healed prior to consenting. Prior lower limb fractures must be fully healed and at least 3 months from injury date at screening.
* Any planned surgeries which may impact physical activity and performance.
* Presence or history of musculoskeletal or neurological disease in addition to DMD.
* Any known allergies or skin reactions to stainless steel, versaflex, and silicon that may cause possible discomfort by wearable sensors.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, cancer, autoimmune or allergic disease that may interfere with the study conduct as per investigator's judgment, excluding untreated, asymptomatic, seasonal allergies at time of screening.
* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
4 Years
12 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3391005
Identifier Type: -
Identifier Source: org_study_id