Would you participate in a clinical trial?

I was approached by a neurologist about participating in a trial of Gilenya as a treatment modality. Essentially, you take a pill daily to see if it helps manage symptoms. Part of me wants to help our cause, part of me is leery of being a guinea pig. What would you do?

Our disease is so all over the place in terms of how any one of us reacts to any “approved” course of treatment that already exists, my gut instinct says no to being a guinea pig

I would participate ONLY if it were a Phase III trial, and I knew that I was getting the actual medication, not possibly a placebo. Placebo is not going to give you any potential improvement. Even with possible risks associated with an investigational medication, I would consider participation if i knew I was getting the real thing.

Oops... forgot to give the link about Gilenya. Here it is: http://www.gilenya.com/index.jsp?utm_source=google&utm_medium=c...

i would. in fact, i asked my neurologist at the mayo clinic to contact me if ever they had any treatments they wanted to test. i'm just desperate to get better and be "me" again. i would do anything to be able to walk again.

It depends on how you are doing. Early on, I would have tried just about anything. Now, my CIDP is pretty well controlled by a combination of IVIG and Imuran. I’m weaker than I used to be, but fairly functional. I would not take the risk of losing what I have.

So, my personal opinion: if my current treatment was not working, I would give it a shot.
Bill

I have participated in a clinical trial, but it was to do more than manage my symptoms, it was to take them away! I had a stem cell transplant at Northwestern Univ in Chicago. In April of last year I did this and now all my symptoms are GONE! No more IVIg, prednisone has been weaned down to almost nothing and I am getting stronger and stronger. You can read my story at: http://wendyssct.blogspot.com and find more info at clinicaltrials.gov - in search bar type: "CIDP and Chicago" to see if you qualify. Be a guinea pig for the right reason! Get rid of CIDP, don't just "manage" it.

Thanks for the input! I asked about leaving the study if my symptoms returned and was told I could leave at any time. My symptoms are well managed with IVig right now so I am hesitant to change that. I can take care of my family and still work fulltime. I would love to help with the study but I am not sure now is the time.

I too participated in trial at NW so I would have to say YES. If nobody ever tries new medicine how are we to know about advancements. It is a personal decision but part of my decision was that it could help other people. I’m not positive but I think someone on one the CIDP FB pages is on Gilenya, I will ask and get back to you.

Hi. I would suggest researching the drug and checking out the side effects before making a decision.

Hi tlb213:

I went on the Gilenya website to read about participating in the clinical trial. Feeling desperate to want to feel better, I thought heavily about it, but unfortunately, there was no where near me that was participating in the trial. Additionally, the more I thought about it, I remembered that in a test trial, someone receives the new drug and someone else receives a placebo. And then I thought, what if I'm in the group that receives the placebo and get worse or relapse again? I don't want to take that chance. Right now I need meds that will truly improve my quality of life.

Good luck!

Lisa in MI

Lisa,

If the trial is in Stage 3 then there would be a chance for a placebo. Not in Stage 1 or 2. There are a lot factors in making such a decision. Usually if you are given a placebo and start to relapse, you are then given the medication. I am glad I did HSCT even with the risks. I am off all CIDP treatments. That is the first time in 10 years. I still have pain but I am gaining strength everyday. My fatigue level is so much better. I have energy at the end of the day even with more exercise. While its not perfect, it’s better than I ever felt with IVIG, Plasmapharesis,steroids, and all the other immune suppressant medications I tried. IVIG kept me fairly stable but the side effects were sometimes as bad as the relapse. Good luck!

It is a Stage three trial. You can leave the study at anytime, which is good if you end up in the placebo group and need treatment. That is one of my concerns. As for side effects, Gilenya can slow your heart rate and affect your vision. Those are pretty significant side effects if you ask me. @Mashrub - I understand the need for someone to try new treatments to possibly make progress for the whole group. Part of me would love to just jump right in for that very reason.

Hi Lisa, Just wondering if you would want to message me on here or at ■■■■■■■■■■■■■■■■■ and let me know where you are from in Michigan. I am from Standish. It's 30 miles north of Bay City. Just trying to find others with cidp that live near me. Thanks! Donna

Lisa Jakee Hilton said:

Hi tlb213:

I went on the Gilenya website to read about participating in the clinical trial. Feeling desperate to want to feel better, I thought heavily about it, but unfortunately, there was no where near me that was participating in the trial. Additionally, the more I thought about it, I remembered that in a test trial, someone receives the new drug and someone else receives a placebo. And then I thought, what if I'm in the group that receives the placebo and get worse or relapse again? I don't want to take that chance. Right now I need meds that will truly improve my quality of life.

Good luck!

Lisa in MI

Mashrub, I am so glad to hear to you are now healed. You were fortunate to be able to have the transplant. There are so many who are not able to for one reason or another. Mostly because their current treatments are helping....though they aer not curing like the sct.

Mashrub said:

I too participated in trial at NW so I would have to say YES. If nobody ever tries new medicine how are we to know about advancements. It is a personal decision but part of my decision was that it could help other people. I'm not positive but I think someone on one the CIDP FB pages is on Gilenya, I will ask and get back to you.

Interesting discussion and thank you for bringing this up. I'm one of the founders of LivingWithCIDP.org and BensFriends.org. We have lots of companies coming to us to see if our members want to participate in various trials and we're very cautious about this sort of stuff. There are risks and benefits and we (BensFriends.org) have to be careful about whose clinical trials we publicize here -- if at all. Anyways, I'm following the discussion closely and am curious to read what you all think. It sounds like the majority would be willing to try and help find a cure by participating, if the situation was right.

hi there,

mm mm sorry, this is my first time i write; don t really know if this is the ways i should

to but ???

Well, maybe if you have the chance or time to send me how, where, when etc., how to go about for knowing how this is all about, i mean these dicussions... i would really more then appreciate it.

I am dizzy all the time; yes all the time and would greatly like to know or meet people that

are in the same situation as i. We could then try to give each other Tricks etc., etc.,

on how we deal with this chronic pain all the time. Even anyone that is inte¸rested in the

subject would be greatly appreciated.

Thank you and my God bless you

Madeleine
Lisa Jakee Hilton said:

Hi tlb213:

I went on the Gilenya website to read about participating in the clinical trial. Feeling desperate to want to feel better, I thought heavily about it, but unfortunately, there was no where near me that was participating in the trial. Additionally, the more I thought about it, I remembered that in a test trial, someone receives the new drug and someone else receives a placebo. And then I thought, what if I'm in the group that receives the placebo and get worse or relapse again? I don't want to take that chance. Right now I need meds that will truly improve my quality of life.

Good luck!

Lisa in MI

Right now I'd try anything short of a Voodoo doctor, Gary

I’m sorry. This is not something I want to do. Basically for all the reasons that others have pointed out.n I am one year and 3 months into this and have gone from a wheelchair, to walker and now to a cane when I can remember it. I don’t feel that I would be a good candidate unless things change for worse.

I don't think I would participate myself, simply because I have had so many side affects from treatments that my neuro has tried. It would be just my luck if Gilenya had major side affects to it I would be the one to be affected...8-} Char