450 Participants Needed

Motor Outcomes Evaluation for Facioscapulohumeral Muscular Dystrophy

(MOVE FSHD Trial)

Recruiting at 21 trial locations
MW
KH
LL
Overseen ByLeann Lewis, MSGC
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Kansas Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather information on how facioscapulohumeral muscular dystrophy (FSHD) affects movement and everyday functions such as breathing and wheelchair use. By understanding these impacts, the researchers hope to improve care for people with FSHD and accelerate new drug development. Participants will be monitored over time, with some undergoing additional tests like body scans and muscle studies. Individuals with a confirmed diagnosis of FSHD, either genetically or through family history, may be eligible to join. As an unphased study, this trial offers participants the chance to contribute to foundational research that could lead to better treatments and care for FSHD.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Why are researchers excited about this trial?

Researchers are excited about the MOVE FSHD trial because it aims to develop a new method for assessing motor outcomes in patients with facioscapulohumeral muscular dystrophy (FSHD). Unlike current treatments and assessments that may not fully capture the progression of motor function in FSHD, this trial seeks to validate more precise and reliable evaluation techniques. By improving how we measure and understand motor changes in FSHD, this approach could lead to more effective treatment strategies and enhance the development of future therapies.

What evidence suggests that this trial's evaluations could be effective for FSHD?

The MOVE FSHD study aims to understand how facioscapulohumeral muscular dystrophy (FSHD) affects movement. Research has shown that specific measurement methods for FSHD can improve patient care and aid in drug development. This study will track changes in movement and daily activities over time to assess FSHD's impact on breathing and mobility. By identifying significant changes in movement, the study seeks to guide better treatment plans. Although this study does not test a specific treatment, it is crucial for enhancing future care and therapies for FSHD.12345

Who Is on the Research Team?

JS

Jeffrey Statland, MD

Principal Investigator

University of Kansas Medical Center

RT

Rabi Tawil, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including motor and functional outcomes specific to FSHD, spirometry, and other baseline measures

Baseline
1 visit (in-person)

Longitudinal Follow-up

Participants are followed for a minimum of 3 years with periodic assessments to collect motor and functional outcomes

3 years
Annual visits (in-person)

MOVE+ Sub-study

Sub-group of participants undergo additional assessments including whole body MRI, reachable workspace, and optional muscle biopsy

24 months
Periodic visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main study period

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+

University of Rochester

Collaborator

Trials
883
Recruited
555,000+

Dyne Therapeutics

Industry Sponsor

Trials
3
Recruited
640+

FSHD Canada

Collaborator

Trials
1
Recruited
450+

AMRA Medical

Collaborator

Trials
1
Recruited
450+

Seattle Children's Hospital

Collaborator

Trials
319
Recruited
5,232,000+

Avidity Biosciences, Inc.

Industry Sponsor

Trials
8
Recruited
960+

Hoffmann-La Roche

Industry Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

University of Nevada, Reno

Collaborator

Trials
34
Recruited
20,200+

Springbok Analytics

Collaborator

Citations

Motor Outcomes to Validate Evaluations in FSHD (MOVE ...The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time.
Motor Outcomes to Validate Evaluations in FSHD (MOVE ...The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time.
Motor Outcomes to Validate Evaluations in FSHD (MOVE ...The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, ...
Update: Motor Outcomes to Validate Evaluations in FSHDThe purpose of this study is to understand functional motor assessments, define which assessments are meaningful to people with FSHD, and if ...
Motor Outcomes to Validate Evaluations in ...MOVE FSHD addresses the barriers to clinical trials in FSHD by helping to validate motor, clinical and patient reported outcomes, as well as potential.
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