When I was first diagnosed with Parkinson’s disease I went online and signed up for newsletters, free publications, and became a member of several major Parkinson’s foundations. As you may have guessed, I have collected tons of information and the one thing all these sites suggested is volunteering for clinical trials. Yet for some reason, I did not think they were talking to me? Maybe that was the ‘denial’ part of me; if you take part then you acknowledge you have Parkinson’s.
One day a friend gave me the phone number from an advertisement, looking for volunteers for a Parkinson’s study. I asked my neurologist about it and with his encouragement I called the number, left my name, and did not think twice about it. After a few months, I received a call from a research facility and they asked me if I would come in and try out for a study on a new drug. By this time I finally figured out that the only way for Parkinson’s researchers to test new drugs and other related ideas was for me, a person with Parkinson’s to volunteer. Again, a little denial can go a long way.
Before the final selection for the trial, I had to qualify to see if I was a proper fit. This involved the standard Parkinson’s exercises (see below), a physical; EKG, blood pressure standing and lying down, urine sample etc. and many forms with as many questions. For my pre-admission examination, I was there for about four hours and that was only to see if I qualified to even participate.
This was a first phase trial involving the testing of an enhanced Levodopa, the gold standard for Parkinson’s medication. Basically, they are trying to create a super Levodopa that last longer and has fewer side effects. There would be a second phase and maybe a third phase depending on the results of the data collected in the previous trials.
Everything involved in this clinical trial from the drug development to its testing, sponsored and paid for by a pharmaceutical company which stands to make millions if the new drug earns approval by the FDA. So there was no expense overlooked; they designed the drug, the study and were in control of everything in the test and all the procedures to follow.
The pharmaceutical companies hire out to hospitals and research facilities to administer their test. The facilities are not involved at all in interpreting the data, only the sponsor of the test will have access to this information and their personnel will interpret the entire study. For example, I was given the enhanced Levodopa on one day, a regular Levodopa on another day and a placebo on another day. No one, not I nor anyone at the clinic knew which was which, on what day I was given what. I could make an educated guess since I know how my drugs interacted with my system, but it was only a guess.
So this is the background for my first clinical trial. They accepted me and I had a month to complete the program. The information I have given you in this post is more than I knew about clinical trials at the time. I had never been involved in anything like this so in my mind I had this picture of me taking the drug or a placebo and being watched for any reactions. While a bit of that is true, there was so much more to it.
Stay tuned for Parkinson’s and Clinical Trials, Part 2
Below are the Parkinson’s Diagnostic Exercises that I do when I see my Neurologist and are a big part of the clinical trials.
Parkinson’s Diagnostic Exercises
- Snapping thumb and index finger together x10, each hand
- Index finger to the tip of your nose x10, each hand
- Flip palm of hands up and then down x10, each hand
- Open and close hands x10, each hand
- Walk 20 paces out and back again
- Stomp foot on floor x10, each foot
- Sit and stand up from a chair
- Fall backward as someone catches you
- Hold out arms in front of you
- Say months of the year backward
- Count backward from 100, every 9th number
- Point out color patterns from memory after they light up.
- Say the color of each word as they appear