The study is a double-blind, placebo controlled trial. The way it is set up is this:
The subject (Lily) is randomized into the control group, or the study group. The results of this are not known to anyone. During week one, the subject starts out on "Bottle A" of medication. This bottle could have Ganaxolone, or it could be placebo. This medication is titrated up to the full dose (meaning we start at a small dose, and slowly work up to full strength) over a couple days.
After a 24-hr EEG, Phase 2 begins. The subject remains on Bottle A, and Bottle B is added. Bottle B is titrated just like Bottle A was. At this point, ALL subjects in the study are getting Ganaxolone. You just don't know what bottle has the med. Some people get it starting with Bottle A. Others don't get it until Phase 2 with Bottle B.
So. At the end of Phase One, Lily was having a rough go of it. She was having tons of spasms, all through the day. I felt like she wasn't making as much eye contact or responding to her name as well (and since I'm the mom & around her most of the time, I get to make that call. :) ). And her EEG was a COMPLETE mess. NOTHING even remotely resembling normal. Tons of high volt spikes & waves, complete chaos. Total hypsarrhythmia (although Dr. LA called it only hyps while she was sleeping; looked like hyps to my untrained EEG reading eye).
This led me (and [my] dad, he was here this week) to
So, Lily started Bottle B (and continued on Bottle A, remember) on Wednesday afternoon. Since then, she has had drastically reduced clusters of spasms. In fact, I think since then she's only had six total clusters. Yesterday she had no spasms after 10:30am. She had one cluster this morning (15 spasms) after she woke up (which, all things considered, was to be expected because she got the nighttime dose early last night [at 6:00pm instead of 8:00pm] so we could be discharged from the hospital a little early). So she'd gone 14+ hours without a dose of the med. Then she had two small spasms when she woke up from her nap this afternoon, again when she was due for the next dose.
And I think (and dad concurs) that her eye contact & responsiveness is better.
So, this reinforces my
(The worry is, of course, that she was getting Ganaxolone in Bottle A & it just didn't work for her. That's the risk you take with any epilepsy med; we just have/had high hopes for this one.)
We bump up to the highest dose of Bottle B tomorrow afternoon. The next few days should be telling. And of course, hopefully her EEG will be much clearer than it was last week. That sucked. A lot.
Dad leaves tomorrow (BOO!!!!), so the twins & I will be on our own for a few days. My mom is coming down on Wednesday with Very Good Friend Donna, and Toddy arrives back on Friday night. My 30th Birthday is Saturday and I think we're going to make the trek over to Disneyland. Fun times, and plenty of photo ops.