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Quarterly Newsletter
   Summer 2021
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Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD (ReSolve FSHD)

There are currently 8 recruiting sites in the United States and 3 sites in Europe.  With grant funding from Dyne Therapeutics, we are in the process of adding 3 additional sites in Europe.  


69% of our participants have completed the study! We expect to be completed in 2022!

Thank you to everyone who has remained in this very important study, even through COVID-19 and adding an additional visit. 

Finished ReSolve and want to move on to a new study?

Join our MOVE FSHD Study!

 
The CTRN is enrolling participants for a new study, Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD). It aims to:
 
  • Hasten drug development for FSHD
  • Improve care delivery by creating a standard protocol that will help predict outcomes such as the need for orthotics, ambulation aides, and respiratory support.

We will recruit 450 participants with FSHD. Visits are designed to occur in conjunction with your normal clinical visits, about once or twice a year. You will be followed over the course of 3 years. Assessments may be done remotely during the COVID-19 period.

Who is eligible? Anyone with a FSHD diagnosis! You do not need genetic confirmation. You do not need to be ambulatory. Children under 18, women who are pregnant or may become pregnant, and those who are currently participating in clinical trials can also participate!

We hope many participants in the ReSolve study enroll in this study so that we can follow you long term.

This study will be collaborating with the Peter Jones Lab, the FSHD Society and Friends of FSH Research.  

If you are interested in participating, please contact your local CTRN site (listed at the end of this newsletter).

Here is also a quick Fact Sheet for more information! 
MOVE+ Sub-study
 
We will be enrolling 200 of the MOVE FSHD Study subjects for a sub-study, which will include muscle biopsy and MRI. If you are already enrolled in MOVE, you can tell your study coordinator that you are also interested in participating in this sub-study, but it is not required.

Inclusion criteria:
  • Enrolled in MOVE FSHD
  • Between 18-75 years of age
  • Symptomatic limb weakness
  • Able to walk 30 feet without the support of another person (participants are able to use orthotics, walking sticks, and canes)
  • Both TA muscles should have a MMT score of between 2-5 on the MRC scale
  • Lower extremity muscle accessible for needle muscle biopsy (our expectation is that 60% will meet MRI STIR+ criteria)
 
Exclusion criteria:
  • Unwilling or unable to provide informed consent.
  • Severe cardiac, respiratory, or orthopedic conditions that preclude safe testing of muscle function
  • Use of anticoagulants such as warfarin or novel oral anticoagulants
  • Malignancy with ongoing treatment with chemotherapeutic agents or anabolic agents
  • Use of immunosuppressants including prednisone within 6 months
  • Pregnancy
  • Recent or ongoing infection
  • Presence of contraindication to performance of MRI: pacemaker, metallic foreign body in eye, brain aneurysm clip (unless documented as MRI compatible)
  • Any other medical condition which in the opinion of the investigator would interfere with study participation.
In the News
Avidity partners with the FSHD CTRN!
 
Avidity Biosciences, Inc., a biopharmaceutical company based in La Jolla, CA, has announced its support of the FSHD CTRN's latest study, Motor Outcomes to Validate Evaluations Plus (MOVE+) Study. This study will be important in developing future clinical trial protocols in FSHD.

Read the full press release
here.
Recent Publications


Members of the FSHD CTRN recently published the data from the "COVID-19 Impact on Muscular Dystrophy Survey." You can read the article here.
The FSHD Clinical Trial Research Network (CTRN)

The FSHD CTRN has expanded!  With the help of the FSHD Society, the FSHD CTRN has added 4 additional sites in the United States: 
  • Stanford University- Dr. John Day 
  • University of Texas Southwestern- Dr. Jaya Trivedi 
  • University of Colorado Denver- Dr. Matt Wicklund
  • University of Florida- Dr. Sub Subramony 
While these four new sites are not participating in the ReSolve Study, they will be participating in the MOVE FSHD Study! Please see site contact information below for future studies.
Don't worry! If you did not get a chance to enroll in the ReSolve study, there are other options available.
Contact your local site to see what other studies may be available to you! 
FSHD CTRN Site Contacts 
 
Kiley Higgs-University of Kansas Medical Center
Study Project Manager
Phone: 913.945.9922

Ksims2@kumc.edu
 
Leann Lewis- University of Rochester Medical Center
Lead Clinical Research Coordinator 
Phone: 585.275.7680

Leann_lewis@urmc.rochester.edu

Katie Roath- University of Kansas Medical Center
Clinical Research Coordinator 
Phone:  913.945.9928

kroath@kumc.edu
 
Mary Yep- Kennedy Krieger Institute
Clinical Research Coordinator 
Phone: 443.923.7318

Yep@kennedykrieger.org
 
Jennifer Huynh- University of California Los Angeles
Clinical Research Coordinator 
Phone: 310.825.3264

jenniferh@mednet.ucla.edu    
 
Marco Tellez- The Ohio State University
Clinical Research Coordinator 
Phone: 614.688.7837

Marco.Tellez@osumc.edu 
 
Corrie Moreau- University of Washington
Clinical Research Coordinator 
Phone: 206.685.2028
    
cmorea2@uw.edu    
 
Sarah Moldt- University of Utah
Clinical Research Coordinator 
Phone: 801.585.9399

Sarah.moldt@hsc.utah.edu
 
Jodie Howell
-Virginia Commonwealth University
Clinical Research Coordinator
Phone: 804.592.1859
jodie.howell@vcuhealth.org
 
Veronica Stevens- Stanford University 
Clinical Research Coordinator
Phone: 650.725.4341

NeuromuscularResearch@stanford.edu

Osniel Gonzalez Ramos- University of Texas Southwestern
Clinical Research Coordinator
Phone: 214.648.2926

osniel.gonzalezramos@utsouthwestern.edu 

Brianna Blume- University of Colorado Denver
Clinical Research Coordinator 
Phone:303.724.6386

brianna.blume@cuanschutz.edu 

Jamie Bolling- University of Florida
Clinical Research Coordinator
jamie.Bolling@neurology.ufl.edu
Thank you for your participation in our research!
The FSHD Clinical Trial Research Network
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