On Friday, Eric took Caleb on the final screening visit for the Phase III STX209 drug trial. We did the phone screening ages ago, September, 2011 to be precise, and I wrote about it at that time (STX209 – You’ve heard of it, right?). That was when we discovered that, in order to do the study, the Celexa would have to go. There are no SSRIs allowed during the study.
We started talking about taking him off the Celexa then…and we continued to talk about it and drag our feet and gnash our teeth until August of this year when finally the stars aligned. The doctors and study people were all ready. Eric was ready. It was just up to me to say, “Let’s do this.”
It wasn’t easy. There was one moment, the night before we started the washout period in August, when Caleb looked at me with such love and trust that I very nearly pulled the plug on the whole idea. How was I going to take away something that I knew was helping him for a chance that we might get something better. I spent a long, sleepless night crying and finally decided to go with what has gotten me through all of the hardest steps on this journey...hope.
Prior to this visit, we had received a long e-mail from the study coordinator so we knew what to expect, we just hadn’t expected Eric to have to do it alone. It broke my heart to miss this, it was so unfair to leave the two of them to go this alone but it couldn’t be helped.
They began by reviewing the study and signing the consent form to go forward with the study. After that there were more forms. Of course there were more forms!! They included a basic demographic form and medical release forms so the study doctors and coordinator could contact and share information with Caleb’s doctors. Eric watched a short video explaining the main questionnaire used throughout the study, the Aberrant Behavior Scale – Community (ABC-C), and then he filled out the actual form. He wrapped it all up by completing the Visual Analog Scale questionnaire.
Then he met with the pediatrician, she reviewed the study criteria, his medical and surgical history, current medications and did a physical examination with Caleb. One of the things she did was an ASD screening. What Eric and I found interesting is that Caleb only met two of the criteria. Interesting since C has a PDD-NOS diagnosis. It’s interesting how many different opinions we have had on this over the years. 1. He doesn’t have it but it’s good for extra services, 2. No, he does not have ASD, 3. Yes, he has ASD, it’s on his IEP, right? and 4. He doesn’t have ASD. OH, wait, that’s only 2 opinions. The doctors (1, 2 and 4) and the school (3) ((Yes, this IS a sore spot with the school, even his super awesome we love them so much school!)).
They ended the day with urinalysis, EKG and bloodwork. Yes, the EKG and bloodwork sucked. I am glad I wasn’t there for these…everyone should be glad I wasn’t there for these. Mama Bear comes out to rip heads off e.v.e.r.y.t.i.m.e…and these smart and helpful people need their heads to keep doing the good work they’re doing. Even though it involves torturing small children…mostly my small child. Grrr.
I am sorry I missed the urinalysis though, it was the first time anyone has asked Caleb to pee in a cup. Eric got to hold the tiny cup. I really, really wish I could have been there taking photos of Eric as he realized Caleb didn’t know how to stop mid-stream to avoid an overflow. Those would have been frameworthy!
I was aware that there was a chance that Caleb wouldn’t be affected enough by his anxiety to qualify. When I asked Eric about this he said there wasn’t even a question that he qualified. Um, yay? I’m glad he qualified, don’t get me wrong, but it just sucks to know how obviously he struggles. It’s not something we think about daily so when we have to face it, it hurts.
The entire visit took 3 hours. Yeah, THREE hours. There was one slight hitch during the visit that added about a 1/2 hour…Caleb is study participant number 9 for this location. This may not seem like a big deal but it is a tremendously exciting milestone. You see, this is a small study location and historically they have struggled to find enough participants to even make being a study site worthwhile. In fact, it’s been so difficult that they believed that they would only be able to find 6 – 8 participants. Obviously, if Caleb is #9, they surpassed that goal which meant they had to get approval from the internal review board to change the study parameters. Permission was given earlier in the week but a slight mix-up resulted in the wrong paperwork being stamped. It took some time to clear up but they did it.
That night Eric fell asleep an hour before Caleb’s bedtime and didn’t move, except to pull the covers over himself, until the next morning. It was emotionally and physically draining. Caleb, on the other hand, was fine after he got his reward…a footlong meatball sub from Subway ((Subway! Subway! Eat fresh!)). We thought he would eat half of it at dinner and have half for lunch the following day. Saturday at lunch he at the 2nd half of my meatball sub because he finished his entire sandwich the night before. Holy moly!
So, what lies ahead for us on this new adventure?
- Visit 1 – Start medication, complete the Vineland Assessment & behavior forms ~2.5hrs
- Visit 2 – Labs (bloodwork) & behavior forms ~1hr
- Visit 3 – Labs (urinalysis & bloodwork) & behavior forms ~1.5 hrs
- Visit 4 – Labs (urinalysis, bloodwork & EKG), Vineland Assessment & behavior forms ~2.5 hrs
- Visit 5 – Visit 5 is short if we decide to not enter the open label extension study. Otherwise it will also be Visit 1 of the open label (treatment with arbaclofen for 2 years, visits average every 3 months) ~2.5hrs
I think the only way we don’t do the the Open Label extension is if we have to stop this study before it is completed. We haven’t really questioned that part, it was the potential of getting the placebo that we struggled with.
5 thoughts on “And it begins…”
Harry loves peeing in the cup!
I don’t think we will hear Caleb complaining about it…how can you not enjoy that as a boy? Peeing on or in things is practically a hobby!
RT @BasicallyFX: And it begins…: http://t.co/hqjEpVlA #fragileX
1. I’m jealous that he eats Subway.
2. I thought the same thing – hooray, they are crippled by anxiety enough to qualify!?
3. HE PEED IN A CUP?! Jealous, again. I’m jealous of what goes into him and what comes out, you might say. Weird, I know……
OK, Bonnie…you just made me snort *loudly* The Subway obsession is a little nuts, it’s all he WANTS to eat at this point! Well, that and Doritos.
Ultimately though the same thing goes into Caleb as goes into your boys…our hearts and souls 🙂