Mr. Parkinson Goes to Clinical Trials, Part 2

You have to cry with your own good tears, you have to laugh with your own good cheer.   -Toad The Wet Sprocket

Upon my acceptance into the program, I made arrangements and decided on the week I would check in. I am self-employed so it was not hard to schedule the time. They required me there for 7 days, checking in on Sunday and checking out on the following Saturday and told me to fast the night before and not to take my medication as they had to draw blood upon my arrival.

Levodopa is the type of drug that if you don’t take it at scheduled intervals then you feel the lack of it immediately. The term for this medication as to its’ losing its effectiveness is ‘off ‘ as compared to ‘on’ when it is effective. So I was definitely ‘off’ after fasting without coffee or meds. Upon arrival, I was instantly rushed to a chair to sit down. But even in my lethargic state I could tell something was wrong.

When I did my four-hour examination for admittance, one of the questions was what drugs including vitamins, was I taking and the amounts. The ones I listed were Levodopa, Nortriptyline, and Trihexyphenidyl, along with Vitamin D and aspirin. It seems that one of the doctors for the pharmaceutical company did not like the fact that I was taking Trihexyphenidyl and canceled my admittance without any reason given.

Amanda who was in charge of my case at the research facility, upon telling me what had happened, rushed out, got my meds along with breakfast and coffee. In no time, I was ‘on’. She had been awake most of the night before trying to find this doctor and get this straightened out. We later found out that he was on safari in India.  So I could still do the study but had to wean myself off of the Trihexyphenidyl first and yes, go through the four-hour admittance exam again and hopefully check back in for the program in a month. There is a real shortage of people who can do some of these clinical trials that require you to spend multiple nights so I did not have any reservation about trying again and getting in.

So now a month later I was back in the facility and admitted. Again my stay would be from Sunday to Saturday. I could not have visitors and could not leave the premises except for an emergency. Cameras were everywhere except in the restrooms. Phone calls and laptops allowed, but worst of all for me I could not have caffeine! And all my meds; locked up as the nurses were the only ones allowed to administer the drugs when the study called for them.

My diet was strict and all meals prepared by a chef who followed the exact amount of calories and nutrients for each day of the study. As an example, one day the menu called for cream cheese on a bagel, well I do not eat cream cheese so I asked for peanut butter. It took about an hour to go up the chain of command and approve peanut butter instead of cream cheese and to specify the correct amount!

On the day of admittance, the on-duty nurse told me to rest as Monday would be a busy day. The schedule was Sunday, Tuesday’ and Thursday as rest days and Monday, Wednesday and Friday were busy days. I would soon find out how far off my expectations had been from reality.

I was given a diary to record the events of that week and a synopsis for my busy days which ran something like this. Up at 6:30 in the morning; be ready to draw blood by 7, do my Parkinson’s exercises as described in Part 1, and then an EKG, blood pressure standing and lying down, take my temperature, see the neurologist for question and answer session. Except when I had breakfast, lunch and dinner, this was my schedule every one and a half hours until 8:00 that night.

I had an IV to make it easier to draw blood throughout the day. In addition, there was a computer test involving physical and cognitive exercises that I had to complete once or twice every hour.  And for the entire week I was constantly asked if I was feeling ‘on’ or ‘off’ and they recorded this in accord with the other data. It was on one of the three busy days they administered the new drug. The other two busy days I was either given a placebo or my regular Levodopa. Not anyone except the sponsors of the trial knew which medication I was given and on what day. Upon completion of all the test, everything’s sent to their lab for evaluation.

Though I brought books and my laptop figuring I’d get bored, by the time Tuesday came around all I wanted to do was lie around and watch old movies. I was that worn out. I still had to have some blood drawn and do some of the exercises, but most of my off day I was free to relax.

Sometimes the staff would join me on their breaks to chat a little and find out how I was doing, if I was ‘on or off’. Since I was the only patient involved in the study, I got to know everyone associated with the program. I would sit up with the night nurse and watch a movie or chat. One night, she took me outside for some fresh air and a walk as I was starting to get antsy.

So this was my first week in clinical trials. I’ve been to a few more since then. Some of the new drugs and technologies that I was helping test are up for approval by the FDA. One such device is an app for the I-phone which can record the various Parkinson’s exercises I do to test my progress which researchers can use for further development of medications and applications and hopefully a way to detect Parkinson’s at a younger age and even to find a cure.

So if you want to get involved and be proactive, give of your time and self to a cause that’s close to your heart. It’s the best thing I have ever done.

Thank you to everyone for reading my narrative on Parkinson’s disease, I really appreciate your time and feedback.

Wishing you all the best,                                                                                                         JC