A Low Interventional Study to Monitor Activity Using Wearable Sensors in Duchenne Muscular Dystrophy

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Pfizer
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Updated on 19 February 2024
See if I qualify
glucocorticoids
genetic testing
muscular dystrophy

Summary

The purpose of this low interventional study is to collect data on everyday movement in boys with Duchenne muscular dystrophy (DMD) using wearable activity sensors. The activity sensors could provide useful information beyond what is currently collected by functional (movement, strength) assessments in clinic. This information can help with the understanding of the impact of DMD, and perhaps with how possible treatments can affect this impact.

Details
Condition Muscular Dystrophy, Muscular Dystrophy, DUCHENNE MUSCULAR DYSTROPHY
Age 4years - 12years
Treatment Activity Monitor
Clinical Study IdentifierNCT04254172
SponsorPfizer
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Diagnosis of Duchenne muscular dystrophy confirmed by medical history and genetic testing
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

Current exposure to systemic immunosuppressant agents other than glucocorticoids
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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