Designing our clinical trial

We're getting closer to our submission of the IND (Investigational New Drug) application to the FDA. That's the official request to launch a clinical trial. Based on the timeline of our manufacturing, that submission probably now will be early fall. And we've already started working on it.

One component of the IND is the clinical trial protocol which we are writing using the NIH template. And getting that right requires us to study the way trials are conducted, reflect on the feedback we've received from the FDA and consulting with experts. Our goal is to identify experts more broadly than we have in the past. Here, experts will include those affected by Parkinson's in addition to lab scientists, clinicians and clinical trial experts.

So here is the first question that we want to pose to you - people with Parkinson's.

We are moving to the final steps of manufacturing the drug product, a term that refers to the drug in its final form. In this case that form is tablets. We figured out how to make tablets in 3 different strengths which is important because the protocol will stipulate that participants will start with a very small dose (or placebo) and then over the course of weekly visits for a couple of months, increase the dose.

Big companies would manufacture all 3 strengths without thinking twice. But we are on a shoe-string budget, so see the chance to save significant costs if we were to manufacture only 2 strengths. If we do that, study participants will start with one tablet, three times a day. The next dose level would require them to take 2 tablets, three times a day. If we made all three doses, the next dose level would require them to take 1 tablet of a bigger dose, three times a day. But if we make 2 doses, this dose level would require the study participants to take 4 tablets, three times a day.

It is possible that the participants would need to continue to take 4 tablets, three times a day, for several months.

For a week or two, taking so many tablets does not seem to be a big deal, but for several months? Would the study participants grow tired of taking so many pills and stop taking the drug? Would I be making a mistake to save some money and have only 2 tablet strengths?

Please give me some feedback. This will require you to answer a few questions about your medical condition, and I request that you only answer the questions once. The form does not ask for any personal identifying information so I am trusting you to answer only once.