Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)

Conditions

• FSHD

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Study Details

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).

Key Dates

Start date

Dec 15, 2020

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

450 participants (estimated)

Arms

• Arm: MOVE FSHD Study Visits
  Patients will receive standard of care as determined by their treating physician. Study visits will occur per standard of care and are anticipated to occur at least once a year.

Primary Outcome Measure

10m walk/run [ Time Frame: Baseline - 5 years ]

Central Contacts

• Michaela Walker, MPH
  913-945-9920
  [email protected]
• Leann Lewis, MSGC
  585-275-7680
  [email protected]

Locations (16)

Find similar trials in Los Angeles, CA

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