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   Spring 2019
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Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD (ReSolve FSHD)

ReSolve FSHD has 8 actively recruiting sites in the United States and 3 actively recruiting sites in Europe.  Contact a local site today for additional information!
Recruitment Update:
Over Halfway There!
as of March 1, 2019:

Thank you for volunteering to participate in this very important study to help hasten drug development in FSHD. We are in a very exciting time where FSHD research is rapidly working towards a solution and we hope this study will answer many lingering questions from the past 20 years.  As important as volunteering is, attending follow up visits is as crucial in order to complete the study.  
But we can't get there without amazing participants like you!

-Dr. Jeffrey Statland

Our next goal is to recruit 90 subjects by June 1.
We have enrolled 82 so far!

We thank you all for volunteering your valuable time to participate in this study. This is a crucial study which will be a guide to all future treatment trials in FSHD. This is a team effort and, with your help, we will reach recruiting 220 individuals with FSHD.

-Dr. Rabi Tawil
The Patient Perspective
(A note from one of our subjects)
 
After many years of working in a career I loved, Neonatal Intensive Care Nursing, I had to give it up due to FSHD. I could no longer hold a baby. My job had a purpose. So I was forced to ask myself what meaningful thing can I do now? That’s when I decided that volunteering in clinical studies could give me the opportunity to not only possibly help others with FSHD, but maybe even myself and my family. I am now in my fifth clinical study entitled ReSolve. I found that all my questions and concerns regarding the ReSolve study were addressed to my complete satisfaction. This was also the case with the other studies in which I participated. In addition, all research staff with whom I’ve interacted made me feel comfortable and safe. I have met some very interesting people – all highly skilled and professional. I don’t have access here where I live to caretakers who are experts in this type of muscular dystrophy. Therefore, this is an added bonus for me each time I become involved in a trial.
 
So much has been learned in recent years about the human genome. This knowledge has brought us to the brink of a possible ground-breaking treatment. How exciting it has been for me to be involved in these and hopefully future studies, each of which I believe could bring us one step closer to the ultimate goal. And it has been an honor to be asked to participate in the Patient Advisory Council for the CTRN. 
FSHD Patient Advisory Council (FSHD PAC) Description
A group of people with FSHD were randomly contacted by each CTRN site about participation on this council. People who agreed to be part of this council have met several times in the last 6 months via telephone to discuss various topics of FSHD research. These topics include opinions on study procedures, recruitment, retention and dissemination of information. The information obtained from the Council have helped us improve our current protocol and design of future protocols. We will be presenting on the importance of patient engagement in research at the MDA Conference in April in Orlando, FL!

(Link to Patient Advisory Council packet)

2018 ReSolve FSHD Annual Investigator Meeting

In October, the ReSolve FSHD Team members met in Rochester, NY at the University of Rochester Medical Center for the annual study training and data review. Kudos to the evaluators for a job well done and reliable data!  From this meeting, we were able to make some protocol amendments, such as removing the abdominal and back muscles from the Electrical Impedance Myography testing, as these data were found to be unreliable.

Study Criteria 


If anyone is asking about the ReSolve study, below is the criteria : 

18 month study with a total of 5 research visits
We are actively seeking FSHD1 patients at all 8 sites in the US and all 3 sites in Europe with an enrollment goal of 220 participants.

If you have any questions about these requirements, please contact one of the site coordinators below.  
Inclusion Criteria:

-FSHD1 genetically confirmed OR you have FSHD symptoms with a genetically confirmed parent, sibling or child.  

-Be able to walk 30 feet without the assistance of a person or walker. (Canes, walking sticks, or orthotic braces can be used to complete assessments safely.)

-Leg weakness (i.e. difficulty going upstairs, cannot get up from a seated position without using your hands, cannot walk long distances).
Exclusion Criteria:

-No major heart, breathing, or bone issues that would make study participation unsafe.

-Medication use should not include any muscle anabolic or catabolic agents such as steroids, oral testosterone, or oral beta agonists.

-Women who are pregnant or planning to become pregnant during the course of the study cannot participate. (Those who are postpartum or breastfeeding can safely participate.)
Dr. Leo Wang, Principal Investigator at the University of Washington in Seattle, WA created a webcast about the details of the ReSolve Study. Please feel free to share this with anyone who would like to know more about this study!
Click here!
Don't worry!  If you don't qualify for the ReSolve study, there are other options available.  Contact your local site to see what other studies may be available to you! 
ReSolve FSHD Site Contacts 
 
Kiley Higgs-University of Kansas Medical Center
Study Project Manager
Phone: 913.945.9922

Ksims2@kumc.edu
 
Katie Roath- University of Kansas Medical Center
Clinical Research Coordinator 
Phone:  913.945.9928

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

Leann_lewis@urmc.rochester.edu
 
Mary Yep- Kennedy Krieger Institute
Clinical Research Coordinator 
Phone: 443.923.2697

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

ddeguzman@mednet.ucla.edu    
 
Tabitha Alexander- The Ohio State University
Clinical Research Coordinator 
Phone: 614.293.6953

Tabitha.alexander@osumc.edu  
 
Laura Sissons-Ross- University of Washington
Clinical Research Coordinator 
Phone: 206.543.0081

lsissons@uw.edu
 
Sarah Moldt- University of Utah
Clinical Research Coordinator 
Phone: 801.585.9399

Sarah.moldt@hsc.utah.edu
 
Liz Diaz-Virginia Commonwealth University
Clinical Research Coordinator 
Phone: 804.628.6480

Liz.diaz@vcuhealth.org
THANK YOU FOR YOUR PARTICIPATION IN OUR STUDY!    - the ReSolve FSHD Team
Copyright © 2019 FSHD Clinical Trial Research Network, All rights reserved.


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