Italfarmaco has shared a letter to the Duchenne community which provides an update about navigating trial visits that cannot be adapted for the home setting:
“All of us at Italfarmaco would like to thank the families participating in the Phase 3 EPIDYS trial and in the open-label extension study of givinostat in Duchenne muscular dystrophy (DMD). Your participation is crucial to the success of these studies.
As some families are approaching the end of the EPIDYS study or a 4 month follow up visit in the open-label study, please remember:
- Your site team will help you plan for these important study visits. Contact your site with your questions. Please contact your trial site early to discuss any concerns you might have. They can help you arrange for the supports you might need.
Both studies are testing the effects of givinostat on DMD disease progression, as measured by the time to climb 4 steps and by other functional testing scores. Certain visits include these tests to measure how function has changed. Collecting these measures is key to answer the research questions.
In 2020, sites began using emergency procedures to protect participants’ rights, safety, and well–being during COVID-19 outbreaks. These procedures include performing some trial safety tests at home and shipping investigational drug to participants’ homes.
Some study visits are more difficult to adapt. Participants complete functional tests which cannot be performed at home in this trial. Those test results are used to answer the research questions. It is critical to do these tests the same way for everyone in the trial to ensure the data is valid. Without those tests, we can’t answer the research questions important to regulatory agencies. Your site can request that your visit be delayed if needed. We appreciate everyone’s patience in this difficult time.
If you are a current study participant and have questions, please contact your local study investigator. If you are not a participant and have questions, you can email firstname.lastname@example.org to reach our team.”
Clinical R&D Manager
Clinical R&D Dept.