Patients' Perspective

Patients' Perspective

This page is dedicated to the stories of PD patients who have participated in clinical trials - sharing their perspective so others can make an informed decision to participate in the advancement of Parkinson therapies.

CEP-1347 Clinical Trial Participants Speak Out on the Decision by Cephalon to cease testing

"I am a participant in the CEP-1347 (Precept) clinical trial. I came home from a support group meeting on May 11 to find an email from an acquaintance telling me the study had been cancelled. I went to the Cephalon website and read their press release – it was true. I immediately emailed the other fifteen trial participants with whom I have corresponded over the past two years. None of them had been contacted by their doctors or by anyone at Cephalon. We were in the dark. The following day (May 12) I found out that many of the study centers learned of the cancellation from their participants, who had called with questions. Still no one had received any notification or guidance from Cephalon.

I knew that there were no guarantees when I signed up for the trial. I knew that most trials failed. Additionally I had accepted the risk that there might be an increased risk of cancer because CEP-1347 works by turning off the mechanism for cell death. In the two years I was in the study, I faithfully followed all of the trial’s rules and restrictions.

During the study each participant has two SPECT brain scans: one at the beginning and one at the end of two years. I am scheduled for my 2nd SPECT scan on May 23-25 at the Institute for Neurodegenerative Disorders (IND) at New haven, CT. On May 12 I emailed them and then spoke to them on the phone. No, they had heard nothing. They hoped to let me know the following day if my scan would still take place. (They did not contact me on Friday as hoped.) I had scheduled a personal vacation around this trip – now what do I do? I wait to learn what to do.

The participants have gotten no direction on what to do now. Neurological drugs should not be stopped suddenly. Do we continue taking CEP-1347? Do we slowly titrate off? I stopped cold turkey on Wednesday evening. Maybe it was unwisely done, but it is done. Now will I have adverse side effects from doing this? My doctor was away at the PSG meeting about CEP-1347, and of course Cephalon had provided no guidance. So I wait to learn what should have been done.

At the time of my SPECT scan, I was promised a copy of the scan(s), and also was told that I would be informed of what dose (or placebo) I had been on. These would be provided at the end of the trial. The people at the IND didn’t know and said these details would have to be hashed out. So I wait to receive what was promised.

What would it have cost Cephalon to have waited 24 hours in order to contact the study centers and trial participants? To leave us in limbo is callous, unprofessional, and potentially dangerous to our health. And yes, I still wait.

In the future Cephalon and other drug companies may have more difficulty recruiting people for upcoming clinical trials. Trial participants are partners in research and have the right to be treated with respect. This was sadly lacking in Cephalon’s actions.

Jean B."

My name is Eldon...

"...and I was officially diagnosed with Parkinson's in 1995. I was 67 years old.

During a routine check up with my primary care physician I asked him why I was trembling. "I noticed that. I wouldn't worry about it" he said casually, "you more than likely have Parkinson's";(Parkinson's Disease -- Don't worry about it -- who was he kidding).

Since both my sons-in-law are medical doctors, I asked their advice. They both agreed that I should have the diagnoses confirmed by a nationally recognized movement disorder center, not by a regular neurologist or a family doctor. A few weeks later I had an appointment with Dr. Theresa Zesiewicz at the Movement Disorder Center, University of South Florida. Dr. Z had just been awarded her Fellowship. I was her first patient.

"You have all the classic symptoms of Parkinson's" said Dr. Z. Not the most cheerful news to receive but she took the time to explain the disease and answer my questions. During the next few months I tried to learn as much about this disease as I could. This was when I first learned about clinical trials and I broached the subject to Dr. Z. She explained the intricacies of this stage of the research required in obtaining FDA approval for a new drug, emphasizing how important it is for people with the disease to participate At that time the Movement Disorder Center was recruiting patients for a new clinical trial and I gladly volunteered. Unfortunately I did not qualify.

A few weeks after being rejected, I received a call from Dr. Zs office saying that they had found a trial that seemed to be tailor-made for me and would I mind coming into their office the next day. The trial was being run by the NIH (National Institutes of Health) located in Bethesda MD. I applied, was accepted and within a few weeks I was winging my way to our nation's capital. This was my very first clinical trial.

The NIH is a huge facility, with top notch medical personnel. They explained exactly how the trial was run. I was given a thorough physical exam; still photographs and movies with sound to record my speech were taken. My commitment was to fly to Bethesda MD once every 3 months, The trial was expected to last 2 years. This study had one very unusual requirement. I had to agree to have 2 spinal taps with an overnight hospital stay both times. All during this trial I was given absolutely the best care one could hope for and they paid all my expenses including airfare once I left the Tampa Airport.

J. Eldon Green"