Good news: The US/Canada CoA-Z clinical trial will start enrolling next week! Are you ready?
Look at the diagram below: If you have completed the pre-trial prep (Steps 1 and 2 in the diagram), then look for our next update containing the trial-specific way to start enrollment (Step 3 in the diagram).
If you haven’t completed Step 2 yet, then you can enroll in PKANready here:
Once you initiate enrollment, we will verify that we have what we need to start a process called “Eligibility” (Step 4 in the diagram). Once this is complete and we have confirmed your eligibility (Step 5 in the diagram) we will complete the consent process (Step 6 in the diagram). After Step 6, you will start a process called “Screening” to ensure that the trial is safe for you / your child and that we have all the logistics worked out for you to be able to participate from home. Screening includes things like:
–reviewing in detail your medical history and medications
–identifying the best local lab and working out how to complete blood draws there
–watching a video training you how to store, take, and document your dosing of CoA-Z.
Screening and enrolling everyone is going to take some time, and CoA-Z has to be made fresh and shipped to you overnight. With the holidays, we expect that most people starting the process in December will receive their first shipment in January. We promise to move as efficiently as we can and thank you for your patience as we all work through this process together. We are excited to get started!