Posted by Friends of FSH Research on Sep 14, 2020
The primary objective of this grant is to expand the U01 NIH funded grant (ReSolve Study) to include two European sites. The purpose of U01 grant is to study and validate new outcome measures for future clinical trials. The inclusion of the two European sites allows the ReSolve Study to boost the number of study subjects making for a better study. Clinical outcome measures are what we use in measuring change in individuals with FSHD during a drug trial. Having outcome measures that are validated is critical in all future FSHD clinical trials as they increase the chance that effective treatments are approved by the FDA. Despite the COVID19 pandemic, the European sites continue with the study with a total of 47 subjects. Data analyzed in the US suggested that the study should be extended to 24 months instead of 18 months. Both European sites will add that extra visit as well.
See grant CTRN International Sites.