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