Sooo … I was in a clinical trial recently. It was, uh, interesting being on the other side of the guinea pig fence. The drug did more than expected. And then it was taken away!
But I get ahead of myself.
It was March 1 when this story began. I saw a new specialist and was immediately enrolled in a research drug trial for ostensibly my pain and sleep. Theory: reduce pain, improve sleep as pain and sleep are connected.
March 8 after a week of baseline monitoring, I was put on the research drug, a controlled release, long-acting version of a GABA analogue. I was told there would be different dosages. When I visited the US government’s website on the trial I was in, I discovered that they tapered the dosages up. So week one I was on the lowest dose. March 14 I went up to the middle dose. March 22 I was put on the highest dose, the one they were studying. After a week of adaptation, I was sent on my way with a monitoring watch strapped on and about a three weeks supply of the highest dose. Since March 1 I had to phone in before noon a daily diary of my pain, fatigue, and sleep. I missed a few days, either because I forgot or because the system crapped out on me and I gave up dialling in and getting nowhere. Since March 8 I also kept an evening paper diary of the exact time I took the research drug.
Every time they raised the dosage, the side effects of dizziness, sleepiness, and nausea would appear for a few days, but each time would be less problematic and by the time the next uptick in dosage was due, would be gone. The sleepiness was murder for a couple of days there, but dizziness I’m used to, and the nausea was bearable. The worst part was that I felt nothing. No difference. All these side effects, all this diary keeping, and no good stuff. I started wondering if this drug was going to do anything, and given the researcher’s questions, I think the team had begun wondering too.
And then …
Pow!
I was baking like no tomorrow. Good thing it was only a few days before Easter feasting. I was baking cookies, puff pastry, palmiers, mushroom vol au vent, pavlova — all like I had done before my brain injury. Effortless on my part and tasty on the eaters’ part. When I say effortless I mean not having to actively think each step, check and double check what I had done versus what the recipe called for, not being uncertain about whether the baking time was long enough, working successfully with my ornery oven, even doing something I hadn’t done since the 1990s: making up a recipe from baking principles to use up left-over yolks. I felt like I was being pushed on some sort of fast-moving baking impetus. It was rather weird. And startling. And amazing!
But that’s not all.
I began to walk longer distances, faster, so much so my hip muscles began to ache more from overuse.
But that’s not all.
April 1: I wrote more than I expected to, not only pages for ScriptFrenzy, but a blog post and pages for my brain injury book as well. Could be an anomaly because I have had days here and there of much writing. But it persisted while I remained on the research drug.
April 2: Baking frenzy week began with hot cross buns. For the first time since my brain injury, I got the baking time right without worrying excessively then underbaking.
April 2: My activity level shot up. I did much more than usual online and around the house in one day. My activity level remained up while on the research drug.
April 5: Making strange mistakes, yet I suddenly started dreaming up what to make for an Easter vegetarian main, and I began making it that evening. Successfully too.
April 5: My body temperature began dropping towards normal. Although it had been slowly in the last few months, this was a big shift downwards. I can take my thyroid medication in the way it’s supposed to be taken. Before and after being on the research drug, I needed to take it during breakfast so that it would not raise my body temperature. During the trial, it didn’t raise it at all when taken half an hour or more before.
April 5: I indulged in a Mayan Hot Chocolate at Soma, and it did not increase my body temperature!
April 5: Initiative returned, that is, I could act on a thought, whether the thought was to make puff pastry or to empty the dishwasher or to write a blog post. Holy cow!
April 5: “Fatigue is just friggin’ weird.”
April 5: More active than the current levels of fatigue would normally allow.
April 6: No afternoon sleepiness or down time.
April 6: I winged making icing and got it right for the first time since my brain injury.
April 8: I had increased tolerance to noise for about an hour.
April 9: I woke up without long lines of pain down my arm muscles as well as less pain in my lower back and hips.
April 9: I tolerated and even liked radio music to yoga.
April 9: I was able to read longer!
April 10: My parents told me I’m coherent, together, with it. Calmer. They do not want me to come off the research drug because they see such a big change in me.
April 13: I read on the TTC for the first time since before my brain injury, I mean really read, not just looked at words but absorbed the story, followed the plot, remembered the characters, engaged.
April 16: My sleep has improved enough or stabilized enough that I didn’t mind the sun waking me up early.
April 17: In tests at the research lab, my heart rate is in the 80s. Never has it been that low since the brain injury when taken at a doctor’s office or by a health care professional.
And then it was over. On April 17, I apparently did not qualify for the randomized part of the trial because of my fatigue levels. I gather they had not dropped enough. Well, they may not have, but that shows that by not thinking to include activity levels in the phone-in diary, they missed an important indicator of functionality. Sure my fatigue levels had not dropped dramatically — yet I was no longer having long stints of not moving in my TV chair, my activity level had shot up, and I was no longer paying the next day for high activity levels. It does seem confounding for my activity levels to shoot up yet no commensurate drop in fatigue levels. But there could be all sorts of explanations for that. Clearly, the research designers had not thought it possible that although fatigue levels could stay the same activity level could improve markedly.
But I don’t think I could’ve tolerated the high dosage level much longer anyway. There were some too-calming effects starting to appear in certain systems of my body. It is important to pee after all. On the other hand, I could not have tolerated the placebo at all, given what is going on with me now.
I was put on a tapering dose April 17. New improvements appeared for awhile:
April 18: I laughed at less stimulation. It takes a lot to make me laugh out loud, or I must be in a quiet room with no distractions to laugh. This was something ordinary, a small joke, and I laughed out loud!
April 18: I engaged more on Twitter with less effort than usual.
April 27: I was able to exercise, albeit less than two-thirds of my normal routine, on a day I went out to appointments.
I took the tapering dose (middle dose of the three different dosages) for two days then began gabapentin on April 19. Oh joy. I lost a weekend to a combination of what I would call withdrawal from the research drug and side effects from the prescribed drug. The worst of the withdrawal was my body temperature alternating rapidly from what felt like fever to chills. The side effects were the same as with the research drug but with the addition of stomach pain. Over the last twelve days, the dizziness and sleepiness went, but the stomach aches are beginning to worry me. This is not nausea. I understand gabapentin increases stomach acidity, which means I must take it with food and some sort of stomach-calming medication like Gaviscon. If that won’t help, I’ll have to take something stronger.
Worse, I am regressing. The gabapentin ain’t cutting it.
My baking is not as effortful as before taking the trial drug but it’s no longer creative and as effortless either. Pain is back under my mind control, no longer the drug’s. (I hadn’t realised how much the research drug had been controlling my pain, releasing my mind to do other things, until I transitioned to gabapentin.) Fatigue is beginning to win again; I’m having trouble breathing for the first time in months when I do too much. My activity levels are dropping, and I’m having to do an awful lot of self-talk to get things done. I suddenly realised my daily coffee fix had increased from half a cup to two cups. And I’m becoming cranky. It isn’t like before the drug either in that this crankiness feels more like rebound. I think part of it is I was liking where I was going under the trial drug. I dared to hope for the first time that maybe one day I could participate in society like a normal person again. And now I see it slipping away. That would make anyone cranky.
So what to do?
Having conducted a ton of research in his career, my father knows all about this conundrum. The latest one he’s dealing with is an experimental hormone a few of his patients took. The hormone grows the small bowel. These patients have none or are missing the critical portion. This hormone was like a miracle to them. Their bowels began to work; some were able to come off TPN completely (to read about TPN and the story behind this artificial feeding method, see my book Lifeliner). So much so that when the trial was over and the drug withdrawn, they began banging on my father’s door demanding access to it, going back to pre-hormone life was that bad. But research drugs aren’t usually immediately available in the marketplace anywhere. And this one is needed by so few people around the world, it’s essentially an orphan drug. He’s working with others to make it available.
I am not dealing with horrible bowel issues but cognitive, fatigue, pain, sleep, metabolic issues. I now know what it’s like to see a miracle disappear. And I am fortunate that, unlike the bowel hormone, an alternative exists in the marketplace to the research drug I was on. Two actually.
Gabapentin is what I’m on. It’s the cheapest alternative and covered by the Ontario Drug Benefit program (though I still had to pay full freight because of the program’s deductible). Lyrica would be a better alternative, but I cannot afford it. Some drug companies will provide patients with a research drug under compassionate grounds, but it requires a doctor willing to jump through the hoops and a drug company happy to help even though it will not accrue any benefit to them at all. So while I think about my next step, I’ve upped my gabapentin dosage and upped the amount of Gaviscon on May 1, hoping that’ll bring the good things back. Given how slowly benefits take to manifest in me, it’ll be a few days before I’ll know if it will work or not. Meanwhile, here come the dizzy side effects.
