Done with Week 1

The outside label on the medication pack.

Just had a call from Duke.  We get a call every 4 days while Ian is in the medication phase of the study, just to check on him.

Ever wonder what dosing is like for a clinical drug trial?  I never really thought much about it, but it's not your typical pills in a bottle scenario.






First of all, the pills come in a special pack.  There are 3 doses a day and they are labelled morning, midday and evening.

The doses have to be at least 3 hours apart.

The times they are given have to be logged in the pack.

That has to be initialed by the person giving the dose.

The inside of the pack with the log

So, how is Ian doing with all this?  It's hard to say.  Overall, I don't really see any changes.  His appetite, sleep and general attitude seem about the same.  However.....

There are moments when I see a more playful and engaged child.  They are brief and they may just be coincidence.  There is a 25% chance he is on the placebo.  But, there is a 75% chance he is not.  

The people at Duke still don't know for sure what our status is when we are done with the study.  Seaside apparently did not expect the participants to stay in the study at the rate they did, and running a study like this is expensive.  But, the feeling seems to be that the study has gone so well that they may be directing their attention (and money) toward FDA approval and getting the drug to market.  After all, that is what it is all about anyway, right?

So, we will continue the study.  Our next visit to Duke is next Friday.  And we will continue to hope and pray that this is going to help provide Ian with the help he needs.