Evaluation of Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments of Losmapimod for FSHD1 With Extension

"The main study includes a treatment period of approximately one year. Subjects will receive 15 mg of losmapimod twice daily by mouth; for a total of 30 mg daily. The study drug should be taken with food and the date and time of each dose taken recorded in the subject diary.~Only subjects who participated in and completed all procedures for the main study (Week 60) will be eligible to participate in the extension.~For the extension, subjects will receive 15 mg of losmapimod by mouth twice daily for a total of 30 mg by mouth daily. Participation will continue until 90 days after commercial drug is available post regulatory approval or study termination."