Tail of a Trial

I recently expressed an interest in participating in a Phase II double-blind trial for an already approved medicine - Pioglitazone (which is for treatment of Type II Diabetes) that MAY have benefit towards the treatment of the effects of Parkinson's Disease.  Yesterday was my appointment to review my medical history to see if I'd be allowed into the trial.  Here's what happened:
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Well for starters, the Awesome Fiance is a pretty amazing guy.  Since this was a preliminary exam with minimal REAL information exchanged, I told him I’d just meet him at home and fill him in when I got home afterwards.  I don’t know why I was surprised to see him walking up to me as I was checking in.  He had to walk several blocks in very cold, rainy weather and he STILL doesn't think it was a big deal at all.  He tells me that anyone would do the same.  He stayed with me to keep me company until my name was called – it was very sweet.

I was called to an exam room by a Research Nurse, whom I've met with before.  We reviewed my recent medical history ("recent” being no more than 7 years ago).  I recalled a few allergic reactions to medication, had a list of every pill I take (and when, and why), and from there we checked my height, weight, took a urine sample and did a blood draw.  (My compliments went to the very skilled hands of the phlebotomist … it was completely painless!)  From there, we took my temperature, did two blood pressure readings (sitting and standing) and an ECG – which took longer to set up than to actually run.

Dr. M was the doctor whom I went to for a second opinion when I was first diagnosed last year.  Well, Dr. M is the principal investigator of this study, which is how I found out about it.  Dr. M came in and tested my eyes, reflexes, muscle strength – all normal.  We tested my sense of smell, something that some Parkinson’s patients lose over time.  This is something I rather dread – as a sense of smell is a BIG part of your sense of taste and, well, me loving food and all …

Anyway being presented with the first scratch-and-sniff, I guess I was feeling cocky.  I could have said “campfire” but nooo – showoff that I am, I said it smelled of toasted nuts, maybe cashews, with a mushroom undertone.  Dr. M said “well it just says that it’s supposed to smell like peanuts but sure – we’ll go with what you said.”  Properly embarrassed, I then sniffed the next sample with just my left nostril and said “mint".  Dr. M said I was correct.  For the right nostril, I sniffed and said “uhhhh – I got nothing.”  He scratched again and I inhaled deeply but … I didn’t get anything at all.  “Maybe … the beach?” I said weakly.  “Ok, let me offer some ideas” he said.  “Cola, Cinnamon, Roses, or Paint Thinner?"  I took another deep breath, this time using both nostrils and said “well it’s not paint thinner.  They’ve been painting in the halls of my office for two weeks so I KNOW that scent.  Maybe it could be ….. cola????”  It was, of course, paint thinner.

Aside from getting that obviously wrong, everything else was on target.  I haven’t progressed much since the last time the doctor had seen me (October), which was good to hear.  The study allows for 10 participants from my state and five have signed up, 'tho one who had to drop out due to something the lab work found.  Barring anything unusual in MY lab results (which I’ll hear about in a week or so), I’ll be subject #5.  I’ll go back in a month and we’ll do this all again, only more extensively and I’ll be given my first dose of Pioglitazone.  I’ll be watched for any reactions for about an hour and … and then we’ll just go from there.

I’ll either be given 15mg of the med, 45mg, or a placebo.  The test is scheduled for 44 weeks, with about 6 checks through the testing period to track my response.  Even if I do wind up taking the actual medication, it may do nothing at all, it could slow down the progress of my Parkinson’s, or it could be that Pioglitazone will protect my nerve cells and stop the progression altogether.  Phase I of the test (done on animals) showed that it protects nerve cells - but we need to prove it happens to humans, too.

Clearly this isn't going to be a quick result but it does look like, for now, my time is not limited by the progression of my Parkinson's.  Barring this stuff changing my mood radically (or sprouting a tail), I think we’ll hardly notice much of difference for a while.

Yanno, unless I grow a tail.