UPDATED 8/9/19
Fulcrum Therapeutics has posted on clinicaltrials.gov information about its upcoming clinical trial of losmapimod. The trial is NOT YET RECRUITING volunteers. People can monitor the clinicaltrials.gov site regularly to see if a preferred site has opened. Patients are not restricted to only participating at the site closest to them.
As trial sites open up for volunteer enrollment, the FSH Society will be sending e-alerts to patients and family members. How can you make sure you will receive our alerts? If you are currently getting US postal mailings AND emails regularly from the FSH Society, you are all set. However, if you have received no communications from the Society or only USPS but not email (or vice versa), we may not have your complete contact information. In that case, please email us with your full name, physical address, email, and telephone number. We encourage you to ask all affected family members to do the same.
This study is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study designed to evaluate the efficacy and safety of losmapimod in treating individuals with FSHD. Patients will participate in this study for approximately 29 weeks. This will include a 4-week screening period, a 24-week, placebo-controlled treatment period and a 7 day safety follow-up period.
Patients must have a confirmed diagnosis of FSHD1 and be between the ages of 18 and 65. Fulcrum will provide genetic testing for patients who don’t have a confirmed diagnosis but otherwise meet the criteria for the trial. The study takes 29 weeks and requires that volunteers have an MRI and muscle biopsy.
For additional details and updates on trial sites, please visit: https://clinicaltrials.gov/ct2/show/NCT04003974
I am interested in the Fulcrum Therapeutics (Losmapiomd) clinical trial.
I participated in the ReSolve study at OSU and the muscle biopsy study at the University of Rochester. Please inform me when I can sign up.
Do let the University of Rochester know you are interested in volunteering for the trial, and keep an eye on ClinicalTrials.gov for an update to let you know when Rochester starts enrolling volunteers. https://clinicaltrials.gov/ct2/show/NCT04003974
DO make sure the FSHD Society has your email and address, as we will be contacting patients and families in regions near the clinical trial sites.
I am interested in the Fulcrum Therapeutics (Losmapiomd) clinical trial for FSHD. Please contact me when the trial available in my area, Kansas.
I like soooo many were diagnosed many years ago when there were no DNA Genetic Tests!! I was diagnosed with clinical diagnosis, muscle biopsy and many muscle electrical stimulus test!
I was diagnosed at the College of Medicine & Dentistry in Newark NJ.
If these test/results are good enough, please inform me what can be done to fix this for myself and sooooo many others that are being passed on.
Sal Sofia
I am very interested in participating but I am over the age of 65. If this testing opens up to a wider age group, sign me up!!!
The clinical trial has to be age-restricted to minimize confounding factors, but if the drug is shown to be effective and is approved by the FDA, it will be available to older patients. As a community, we can all do our part by helping to ensure that this study is completed quickly to the highest scientific standards.