An up and down kind of week

Our adventure with STX209 continues.

Since my last post on Monday, Ian has had some rough times at school and at home.  On Monday and Tuesday he came home with only 5 out of 6 smiley faces, and the teacher noted that there seemed to be more anxiety than there had been in previous weeks.

But there have also been more words, and more speech that makes sense.

On Tuesday night, I was trying to get him to turn on his humidifier at bedtime and he flatly refused.  What?  No, no, you have to do it.  Well, he did and then he burst into tears.

What a mean mommy!

I felt terrible because he rarely cries.  Who knows what the medications are doing to his hormones?  Also, he is 11 and the lovely puberty years are looming.  He finally settled down and went to sleep.

On Wednesday my usually happy morning guy was a grump.  During his dressing routine he screamed "Shut up!" at me and I scolded him and turned off his beloved PBS Kids.  He turned it around before he went to school, but came home with a very bad report.  Computer time had been taken away from him twice and he had actually said Shut Up 21 times.

Sigh.

When he got home, iPad privileges were suspended until he did some tasks to earn them back.  It's amazing how sweet he can be when he wants the iPad back!

Then, after dinner, the house was really hot.  I checked the thermostat (which is the kind you turn up and down on a dial) and it was at full blast!  The only one in the house who could have done it would have been Ian.  Weird!  Of course we asked him, but got no real answer as usual.  We told him not to touch it anymore.  But, who knows?  Maybe he thought since he had to turn on the humidifier, he should turn on the thermostat?  Not sure if it's a coincidence or not.

 I'm starting to wonder if we're going to have to baby proof the house for an 11 year old.  As a toddler, when most children his age were getting into trouble and making messes, he was an incredibly easy child.  We did baby proof then, of course, but he was just so NOT curious.  I can only recall one time when he got chocolate candy on a white chair.  (By the way, if you're having a hard time getting pregnant, just order some expensive furniture with white upholstery.  Just saying.)  We flipped the cushion and moved on.

Ian and the chair he got messy

Thursday was, thankfully, a better day.  Ian's class went on a field trip to a deli for lunch.  He behaved, ate his meal, and had fun on the bus.  He did well the whole day until the very end when he hit two of his classmates.  But, we dealt with that when he got home (apology notes) and he had a good afternoon and evening.  His daddy gave him a bath and when I was tucking him in he asked me for "Beach."  This is when we turn on his sound machine with the ocean sounds.  As I was doing that, he pointed to the wall behind me and said, "That's the beach."  It took me a second to catch on.  On that wall are two paintings my Grandfather did of beaches in Kauai.  I've never seen Ian show any interest in any of the  pictures we have around the house!  Loved that he made that connection.

My Grandfather's beach paintings

So, another week in the clinical drug trial is winding up.  Our next visit was moved up to next Tuesday, March 26.  It will be interesting to see what the next few days bring.

Duke Visit March 15

Our second study visit is done!

We drove down last Thursday night.  It had been a stressful couple of days around here.  A large tree fell in the backyard of one rental property, and on Wednesday night a plumbing problem developed at the other one.  I had to jump up on Thursday morning and find a plumber willing to crawl into a tight crawl space to fix a busted pipe while Rob and Ashby were taking a chainsaw to the tree.  Thanks to Kelleher, I got the plumbing issue resolved and got home in time to get Ian off the bus and we got on the road.

Need to give a shout out here to our hosts in Chapel Hill!  My sister Mary and brother-in-law, Jim, have been putting us up for the appointments.  Although the study would provide a hotel room, it is so much easier to stay with family.  Mary has been spoiling me with wonderful dinners and delicious cocktails upon our arrival, which is usually around 6.  Ian loves chasing the cats around and watching them come and go through the various cat doors.  He feels comfortable in the house and always sleeps well.

Comfy and cozy at Mary and Jim's

The next morning we had to get up and going early because our appointment was at 8:30.  It all went pretty smoothly until I couldn't find my car keys, prompting a little bit of panic on my part.  But, they turned up and we got into the garage at Duke by about 8:25.  As we came in, the attendant gave me a ticket with a big smile and asked if we were going to the clinic.  When I said yes, he said he hoped it went well and that we had a great day.  That was such a nice way to start our visit, especially since Ian had decided that he had to go to the bathroom RIGHT NOW when we were about halfway there.  (Never mind that he wouldn't go before we left Mary's house.)  We found a decent parking spot and ran to the clinic and a bathroom.  Hurray!  No accident!

Min (or Ming, not exactly sure) was our nurse and she was wonderful.  She took us to our "usual" room to wait for Wan.  Her son was born the same week as Ian, and we had a good conversation about 5th grade and middle school.

When Wan came, we went over our medication logs from the packets.  She made me feel so good because she praised me on how well I did keeping records.  I know that means so much to these research people, so I did make a real effort to be meticulous and try to dose Ian at about the same time every day.

I had a few minutes to check email while they were doing some things, and I found one from Ian's teacher.  I had asked for her feedback so I could share it with the team at Duke.  She wrote a very positive email, and when I read it to Wan she started to cry!  She was so happy, then I started to cry.  She excused herself and went and got Min and another nurse, Kimberly, and told them the whole story about getting Ian into the study at the last minute and the positive changes that were happening.  It was such an amazing moment, I'll never forget it.  Ever.

Back to the more basic stuff.  We had dosed Ian after arriving, around 9:20.  Then they checked his vital signs.  After that we had to wait two hours to do the blood draw.  We had some time to go get breakfast in the Food Court.  We brought the iPad and Kindle and Ian patiently sat at a table while I got coffee and some breakfast for me at Seattle's Best.  The women working that counter were so nice, just above and beyond.  Even though it was noisy in there, Ian did pretty well.

Settling in to his spot to watch DVDs

After that, it was a lot of waiting around.  Wan had brought her DVD player again, and Ian alternated between the iPad and the movies.  I used the Kindle to keep myself occupied.  (Next time I'm taking some knitting or something.)  Dr. L came in and checked Ian over; he did much better this time.  When it came time for the blood draw, the first thing Stephanie said was, "There is something different going on here."  She said he seemed more engaged and had better eye contact.  And Ian was a SUPERSTAR for the blood draw.  We just sat him on the bed and kept him still and he even WATCHED it this time.  He gave a couple little screams after it was over but that was it.

The view from the room at Duke Clinic

Our longest wait was after that.  It's very complicated with the drug packets.  They have to be brought in on an overnight service, then run through the pharmacy.  We had to wait over an hour for them after the blood draw, but it was okay.  We made arrangements for our next visit, and then we were on our way.

Ian's binder

As we headed to the garage, Ian seemed to be walking with a lot more confidence.  He knows his way around now, and overall the anxiety level is way down.  We got settled in the car and had a nice farewell from another parking attendant on our way out.

Duke Hospital, part of the huge medical complex

Our drive home was fairly uneventful.  We stopped in South Hill for a late lunch and we got back into the River City around 4:30 before the traffic got too crazy.

Back in Richmond!

These visits, in spite of all the sitting around, are kind of exhausting.  But, at the same time, they give me so much hope and the people are so wonderful.  I am so thankful for this opportunity for Ian and hope that this will help all the children affected by FX in the future.

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.

It takes a village

Yesterday I was reminded how many people are involved in Ian's life, and how important they are to me as well as him.

Since we had a two hour delay, I was dressed when Ian's bus came to pick him up.  Ms. Vivian and Ms. Julie are the driver and aide.  We've known them for several years, and they are a great team.  They care so much for the kids that are put in their care every day.  I went out to say hello (and to make sure Ian didn't jump in the big puddle in the ditch!) and they told me how well Ian was doing lately.  There had been problems earlier in the year, but they adjusted things and made it work for him.  I am so grateful for their care and attention.

Ian on the bus

Ian had a doctor's appointment yesterday afternoon that made it necessary for me to pick him up from school.  One of the classroom aides, Mrs. Hines, brought him up to the office.  This woman is fantastic.  She loves Ian and puts up with a lot from him since she has to make him do a lot of his work.  A few weeks ago Ian was very bad and hit her.  I made him type an apology note.  Even though it is part of her job, I knew it had to hurt her feelings.  Goodness knows, she doesn't make much money.  She is one of those amazing people who does the work because she loves the children.  I gave her a hug as we were leaving and told her I appreciate every thing she does for Ian.  I hope that helps the next time he misbehaves!

Ian with Mrs. Hines on a field trip

Our appointment was with Dr. M. who does Ian's medications.  We have a routine at this office where Ian will get a magazine from the rack while I sign him in.  He then takes the magazine out into a hallway area and waits.  Without fail, he has always picked up the Sports Illustrated magazines.  I don't know why, he just does.  And he has done this for years.  It is part of THE ROUTINE.  Yesterday, no Sports Illustrated.  And I had not brought the iPad.  And we were early and Dr. M. tends to run late.  I braced myself for trouble as I tried to get him to look at other magazines or the newspaper. (no, no, NO!)

Awesome.  Well, he handled it better than I expected, thank goodness.  I am so happy he is not a major tantrum thrower!

I am so happy we found Dr. M.  She is so sweet and smart, and she has true compassion.  She is not a Fragile X expert, but she has read everything I give her and has educated herself about it.  If I have a concern, she listens.  She explains what the meds do and don't do.  She is thoroughly professional.  Ian mainly just sits there as we talk, and yesterday he got kind of snippy when asked to get on the scale.  But, he tolerates the appointments and I know he likes Dr. M. is his own way.  Did I mention she is stunningly beautiful?  Seriously.  She is Indian and looks like a Disney princess.  Even at 7 months pregnant, she looks amazing.  I know my boy.  If she wasn't so pretty and sweet, things might be a lot different on these visits.

There are many other people who are part of our village.  Every day I give thanks for them all.

Snowy day and a schedule update

Today we had a snow day.
Last night it poured down rain.  I mean POURED.  I even was dreaming about Niagara Falls.  Then, it thundered and started to snow.  Now, after a couple of inches, the snow is letting up and the wind is picking up.  Being a mom who has experienced power outages before, I am charging up everything I can just in case the wind brings down the power lines.

I just received an email from Duke.  We have been set up for our next 4 visits, but still no news on the extension after we are done.  Still need lots of prayers for that!  In the meantime, we will continue on and hope for the best.

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!