Pregabalin study on FMS pain - help me decide, please!

Discussion in 'Fibromyalgia Main Forum' started by jaltair, Sep 13, 2005.

  1. jaltair

    jaltair New Member

    I received an e-mail response to an inquiry regarding being part of a study of how pregabalin affects pain associated with FMS pain, and I'm trying to decide what to do. I would appreciate any input from those on this Board.

    This is a special study with investigational drug to see how it relieves FMS pain - the generic name of the drug is pregabalin (brand Lyrica), the drug has been approved by the FDA for epilepsy, diabetic neuropathy and herpetic neuralgia, and this is 4th study on FMS. 100 sites in USA and Canada are involved, and 1500 patients are to be part of the study. The investigational trial will require me to go to an office in Fresno every week, and Fresno is about 1 hour 20 minutes from where I live. This would require taking 1/2 day off work.

    The first, second and eighth appointments are longer, 1hr at least, other appointments are about 15 min. 1st day involves exam and blood work up, medicine started on 2nd visit and there is some paper work, 8th visit again paper work and blood tests. Visit is every week.

    The first part of the study is 8 weeks when I would receive the investigational medicine. If I'm a "responder", I go to 2nd phase up to 6 months, and would receive either the investigational medicine or a placebo. When pain or fibro symptoms are worse, I would be out of the study (in either phase). In the 2nd part the investigators want to look to see if how long the medicine stays effective, and if not how quickly symptoms are back..

    I'm torn as to whether or not I should go on the trial.

    I will have to go off all my meds; i.e. Ultracet, Neurontin, muscle relaxers, and Celexa, for one week to "wash out." This scares me as the medications have really helped to stabilize my sleep and pain problems.

    On the other hand, the work up that would be done and the medication would be free to me during the trial. I have no idea as to how much pregabalin costs, and would welcome information from those who have used the drug. I would love to get down to one drug for pain!

    Please, those who have used pregabalin or those who know about this study, let me know your thoughts! Thank you.

  2. jaltair

    jaltair New Member

    and bumping for input . .
  3. Rosiebud

    Rosiebud New Member

  4. matthewson

    matthewson New Member

    I don't know much about pregabalin, but from what you have written about your situation, I wouldn't do the study.

    You say that you work and it would take an hour and 1/2 every week to get the the clinic. You would have to go off all your medications that work for you. I work and I know that I could not function without my meds. I simply could not go to work!

    Also, coming off of the meds you are on is not an easy thing. They all need to be tapered off. Celexa may be the hardest one to get off of.

    I think the deck is stacked against you on this one. If you werent working or didn't take any meds for pain, then this wouldn't disrupt your life that much, but this sounds like it would really disrupt your life and for what? Do they pay for the study and how much? Also with gas prices, you would be out a lot each week and also the 1/2 day off work.

    I know how you feel. You really want to help with the study and that's admirable. But sometimes we can't do what we would like to do. I know in my case, I would be down in New Orleans right now volunteering in a make-shift lab at one of the tent hospitals, but I know that I could not stand on my feet for the required 12 hour shifts. Some people from my lab are going down and I wish I was one of them, but I am just barely making it to work each day and I only work part-time! One thing this DD has taught me is that I have to be realistic about what I can and can't do.

    I hope I haven't come across as harsh. That was not my goal. But, sometimes we need feedback from another person who can look at a situation objectively.

    Good luck to you in whatever you decide to do. Sally
  5. lilac123

    lilac123 New Member

    Hi Jaltair,
    I just now wrote the same question to the board. I called aobut the trial in my area too and got the same info as you. It would be nice to feel like I'm helping with the study of FM and to get the meds for free but boy oh boy the thought of going off the "recipe" I have now is just too scary. After trying many different meds I finally have found this combo that seems to help me maintain.

    I am leaning towards not doing it myself. But, still would consider it if Doc thought it was a good idea. I am going to check with him. Sorry I don't have any answers for you I just don't think for me I could handle the amount of pain I would have. Too risky for me as a reovering alchoholic. I would not want to put myself in jepordy of relapse to drinking because of the pain.

    Sounds like it may be a good drug for treating FM and the lady I spoke with said it would also help in making FM more accepted as a disabling diagnosis if there was one drug that treated it. (??????)

    Thoughts and prayers are with you as you make the decision of what is right for you.
  6. bpmwriter

    bpmwriter New Member

    you can check prior posts under my name for how i responded to the med. the center here in florida would not take patients on several other medications due to the possible problems during the washing out phase. it took them a long time to fill the study because so many of us are on multiple meds. at the time, a small dose of zanaflex was the only thing i was taking so it was easy for me, but your situation sounds different. be careful.

  7. jaltair

    jaltair New Member

    I received the consents from the doctor via FAX today and had a chance to review them. The actual protocol is pretty rigid, and I'm not sure I'd make it through the trial past the first two weeks.

    matthewson - Thanks for your input. I'm thinking along the lines of what you've written and probably won't go into the trial. I would also would go to the areas in need from the hurricane via the Red Cross as I am a public health nurse; however, the problems I have wouldn't allow me to be of much help there. Like you, I have trouble getting through my days. I've been on Provigil for a week now and have noticed a difference in levels of energy. Currently taking 100 mg. It's very expensive, and I have to pay out of pocket for it. Provigil is another drug in trial for FMS. Hopefully, it's proven to be of help, then perhaps my insurance will cover it.

    lilac123 - Isn't that something that we've both looked into the trial? I know how you feel, I'd sure like to help out with it. I, too, have a set regimen of meds that seem to work for me. I'm not sure if I had to go off if the whole thing would be for "naught" as the pain would be back full-force and I'd be eliminated (per the protocol I received today).

    bpmwriter - I couldn't find your post about your experience, could you please give me an approximate date when you posted? What's sad is that only those with mild symptoms will finish the study (at least that's what it looks like).

    rosiebud - thanks for bumping my post!

    Warm wishes to all, Jeannette

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