A Low Interventional Study to Monitor Activity Using Wearable Sensors in Duchenne Muscular Dystrophy
NCT04254172
ABOUT THIS STUDY
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- 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
- 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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Descriptive Information | |||||||
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Brief Title | A Low Interventional Study to Monitor Activity Using Wearable Sensors in Duchenne Muscular Dystrophy | ||||||
Official Title | A SINGLE-SITE, PROSPECTIVE, NATURAL HISTORY LOW INTERVENTIONAL STUDY TO ESTABLISH NORMATIVE DATA OF REAL-WORLD ACTIVITY MEASURES USING WEARABLE SENSORS IN AMBULATORY BOYS WITH DUCHENNE MUSCULAR DYSTROPHY (DMD) | ||||||
Brief 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||||
Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | Ambulatory boys with Duchenne muscular dystrophy who receive care at Nationwide Children's Hospital | ||||||
Condition | Duchenne Muscular Dystrophy (DMD) | ||||||
Intervention | Device: Activity Monitor
Wrist and ankle sensors to be worn continuously for 2-week intervals. | ||||||
Study Groups/Cohorts | Single cohort
There is no randomization or stratification in this study. All subjects will complete the same study assessments. Intervention: Device: Activity Monitor | ||||||
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 | Terminated | ||||||
Actual Enrollment | 2 | ||||||
Original Estimated Enrollment | 20 | ||||||
Actual Study Completion Date | August 19, 2020 | ||||||
Actual Primary Completion Date | August 19, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 4 Years to 12 Years (Child) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT04254172 | ||||||
Other Study ID Numbers | C3391005 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Pfizer | ||||||
Study Sponsor | Pfizer | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Pfizer | ||||||
Verification Date | October 2020 |