In, then out, then in again

This blog is about the STX209 clinical drug trial at Duke.

We've had some complications.

On Thursday, February 21, we received a call.  It's long and involved, but basically it came down to this....we would not be getting the drug in the open label after Ian's participation.  I was devastated.  One of the reasons we were interested in this study was because we were told that we would have the option of continuing the medication after the trial was over.  After all, it could be years until it's approved and it would be a shame to go through the study and discover that it worked great and then have to STOP.  To further complicate matters, a deadline of February 28 was thrown in there AND one of the key doctors was out of the country.   Our next visit had been scheduled for today, March 5, and Ian would begin the dosing on this visit.  After talking it over with Rob, I called Duke back and said no, we did not want to continue under these conditions.

And, that was that.  Or was it?

No, of course not.  Last Tuesday I got away for an evening up to Northern Virginia to see my sisters.  The next morning there were several missed calls from Duke on my cell, but I was busy and didn't get the message until I was on the road back to Richmond.  I'm driving down I-95 and talking to Duke again.  They were frantic to get hold of me, there was STILL A CHANCE!  The doctor who was out of the country was lobbying hard for us to be included in the open label, at least for a year, but we had to get Ian on the medication (or placebo) by the NEXT DAY!  So, I told them yes, we would be there, and then I pulled into a rest stop to make some calls.

I got home in time to get Ian off the bus, but I was too tired to make the drive to Chapel Hill so I decided we would just do a day trip.  And everything was fine until I went down the basement steps to help Ashby with something....

and missed a step....

and sprained both my ankles!!

What I woke up to Thursday morning!

Genius!

So, it worked out that Ashby drove us and I limped around with wrapped up feet and crutches and a wheelchair at Duke clinic.  They set me up in a hospital recliner and I pretty much stayed in it the entire time we were there.  Lunch and ice were brought to me, and I answered questions and listened to directions concerning the dosing.  Ian was a good boy, even during the blood draw.  Ashby got a chance to walk over to Cameron Indoor and see the students camped out for tickets for the Miami game.  We got it done.

At 2:45 p.m., Ian had his first dose.  We were in.

Ian loved Wan and her collection of DVDs!

However, we still don't know if we are.  In fact, we don't even have another appointment set up.  I had a follow up call from Wan yesterday, and she said they were meeting today and would let us know.

Now the question is, will we continue, even if we don't get the open label?  I think we will.  We've gone this far, and when the drug does become available we will have a better idea what to expect.  Unless we are on the placebo (chances are 1 in 4 that we are), then I guess we're just helping out with the study data.   Five days into this I don't see any real changes in Ian, but he certainly isn't any worse off than he was before.

So, we will wait and see what happens....and watch those tricky steps!