NCT04635891 Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)
| NCT ID | NCT04635891 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Kansas Medical Center |
| Condition | FSHD |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2020-12-15 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2020-12-15 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level of clinical care is being provided. Also, the hope is to speed up drug development by gaining a better understanding of how having FSHD impacts motor function and other health outcomes (i.e. breathing, wheelchair use, etc.) and how big a change in motor function would be clinically meaningful to those with FSHD. Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) will have approximately 450 FSHD participants followed for a minimum of 3 years. A subset of MOVE FSHD participants, approximately 200, will participate in the MOVE+ sub-study which includes whole body MRI and reachable workspace, as well as optional muscle biopsy and wearable device (US participants only).
Eligibility Criteria
Inclusion Criteria: * Genetically confirmed FSHD (types 1 or 2) or clinical diagnosis of FSHD with characteristic findings on exam and an affected parent or offspring. Exclusion Criteria: * Unwilling or unable to provide informed consent. * Any other medical condition which in the opinion of the investigator would interfere with study participation.
Contact & Investigator
Jeffrey Statland, MD
PRINCIPAL INVESTIGATOR
University of Kansas Medical Center
Frequently Asked Questions
Who can join the NCT04635891 clinical trial?
This trial is open to participants of all sexes, studying FSHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04635891 currently recruiting?
Yes, NCT04635891 is actively recruiting participants. Contact the research team at mwalker20@kumc.edu for enrollment information.
Where is the NCT04635891 trial being conducted?
This trial is being conducted at Los Angeles, United States, Stanford, United States, Aurora, United States, Gainesville, United States and 11 additional locations.
Who is sponsoring the NCT04635891 clinical trial?
NCT04635891 is sponsored by University of Kansas Medical Center. The principal investigator is Jeffrey Statland, MD at University of Kansas Medical Center. The trial plans to enroll 450 participants.