You are here

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

Last updated on February 21, 2020

FOR MORE INFORMATION
Study Location
Nationwide Children's Hospital
Columbus, Ohio, 43205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Duchenne Muscular Dystrophy (DMD)
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4-12 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT04254172
Pfizer
Recruiting
A Low Interventional Study to Monitor Activity Using Wearable Sensors in Duchenne Muscular Dystrophy

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
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 Recruiting
Estimated Enrollment
 (submitted: January 31, 2020)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 11, 2021
Estimated Primary Completion Date August 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2020

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now