I Am In A Clinical Study!

 

Treadwell NY February 2021

Introduction

For the last six months, I have not been doing so well. My limp has gotten worse, I frequently suffer from fatigue and I am out of breath a good deal of the time. The times when my medication is not working (off periods) have increased from 20% of my day to about 40 to 50%.

What I Did

I was/am extremely frustrated with my current condition and decided that something needed to be done and done quickly.  Three months ago, my search for a clinical study began. At first, I looked into a study in which the medication would be delivered via an implant in my arm. I made it through an online and a telephone screening, but the sight coordinators never got back to me.

Next I moved to the ABBVI-951 clinical study. below is the best description of the study that I found:

ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's Disease. The study has two treatment arms . In one arm, participants will be given ABBV-951 plus oral placebo (does not contain treatment drug). In the second arm, participants will be given placebo solution and LD/CD tablets. Adult participants with advanced PD will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites across the world.

In one arm, participants will receive ABBV-951 solution as a continuous infusion under the skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules containing LD/CD tablets. The treatment duration is 12 weeks.

 

Please allow me to translate. I am extremely lucky to be one of only 130 people world-wide to be selected for a clinical study in which the medication will be delivered via pump under my skin. It is a double blind study, so neither I nor the medical staff at the study site will know if I am receiving the drug or a placebo. If I am receiving the placebo, then the additional pills they give me will be my current medication. If I am receiving the actual drug, then the pills that they give me will be a placebo. If I am in the control group (people receiving a placebo), then when the 12 week study is over I will receive the actual medication. If the medication works for me, then I will get the pump and the medication itself for free for the next two years. The first two phases have shown a great deal of promise and people in the Parkinson's disease community have had positive things to say about the study results so far.

 

Two Visits So Far

At my first visit, they collected samples, ran tests and had me complete paperwork. I had my second visit to the study site Thursday, March 4. I finished the first day of training on the pump itself today. It is a little complicated, but I passed the quiz after the training, so I think I am ready to start using it. There will be an additional hour of training on the pump at my next visit on March 18 and hopefully, soon after that, I will start on the medication (or placebo). I am also using a watch that sends important health data to the study team. It is a good thing that I am a person who likes to use electronic gadgets because on March 18, I will also receive an electronic diary to keep track of my symptoms. Soon there will be even more chargers plugged in all over our apartment!

The pump is different from the one that I have shown many of you before. I asked if I could take photos of it today, but they said that I am not allowed to photograph any of the equipment or to share a description of the pump.

It Was Not Easy

What I have just conveyed to you in less than a page actually took about 10 weeks to accomplish. I searched the web for studies, filled out online forms, sent medical records, and emailed and phoned site coordinators. If this seems daunting, it is because it was. I firmly believe that hope is a process, it is a verb and it requires action on your part. I decided that I had to be very hopeful!

 

What I Have Learned So Far 

You should always be on time since there will probably be a team of people waiting to work with you. I am working with two doctors, a researcher, a site coordinator and another individual who appears to handle all the technology.

While all five people were not working with me at the same time, at least two of them were. I spent four hours in which I was the center of attention of multiple people at the study site. Even for an extrovert like me, this is an exhausting process. If you are going to take part in the clinical study, you should prepare yourself for this.

Not Putting All Of My Eggs Into One Basket 

While I remain hopeful that this new treatment will be extremely beneficial to me, I cannot just assume that things will get better. I am also exercising a lot more than I have in the last six months. For my birthday, my wife and my family all chipped in to buy me a spinning bike. I am also using the Peloton app and have taken one cycling class a day for the last 14 days! I already feel much better. I am not really certain whether or not my off times have decreased or whether I just feel better during the time that my medication is working. What I do know is that increasing my level of exercise can only help. There is a tremendous amount of research available which correlates the level of exercise with the progression of Parkinson's disease. In short, current research indicates that the more I exercise the slower my disease will progress.

The Peleton Hack!

  

Thank You

Throughout this entire process, my wife, son, extended family and a great deal of friends have been cheering me on. I greatly appreciate all of the support you have given.  I will do my best to keep all of you informed. I remain hopeful.

On a side note:

March 3, 2021, First Shot Done!

 Stay hopeful and thanks for reading!

John