Lyrica Pregabalin Study Starting

[timberdoodle]

Hi everyone,

In a recent post, I mentioned that I would be checking with my uro about Lyrica when I went this week. As it turns out, there is a study starting in the next week or two (Dr. Shoskes is involved, as he mentioned in a previous post) at several clinics around the country.

The study will follow several CP/CPPS patients who will be taking Lyrica in a 2 to 1 randomized trial (i.e., 2/3 will receive the drug; 1/3 will receive placebo). The drug is already FDA approved for some other conditions, and this study will help determine if it is useful for chronic prostatitis / chronic pelvic pain syndrome patients.

Anyway, I am enrolling in the study at Cleveland Clinic, and I thought I would post my experiences in the study and with the drug over the next couple of months. I won't know if I'm on placebo at first, but about half way into the study, everyone has an opportunity to take the actual drug.

I'll update this post over time and let you all know how it works out.

[timberdoodle]

I had my first interview today to start the study. I had to fill out the NIH chronic prostatitis / chronic pelvic pain syndrome pain score questionaire. I also had to get some blood work done to make sure my liver can handle the drug. If the lab work checks out, I should be able to start the drug or placebo next week. I will post back to let you know what effects, if any, this drug has.

[timberdoodle]

I started on the drug/placebo this week. It's interesting that in the initial questionairre they ask you whether or not you expect your symptoms to improve while you're in the study. I found myself circling "yes," even though I really don't have any way of knowing until going through with it.

I have a sense that I'm on the real drug and not placebo, because I have been pretty tired and have had a dry mouth, both of which are symptoms of Lyrica. It's really bizarre not knowing if you're on the drug or on the placebo.

Strangely, I am not sure if I want the drug to help or not. Of course I want to feel better, and I hope this drug does the trick, but on the other hand, this drug has done some nasty things to rats in various studies, and I don't know if I want to be on it long-term.

I'm starting on a small dose for two weeks, then a larger dose, then moving up to the maximum dose (600mg/day) after 4 weeks. The study ends at 6 weeks.

So far there has been no significant impact on symptoms, but it's only been a day and a half.

[gifford]

3/31/06
I just got an invitation today to join a Pregabalin/Lyrica trial at Northwestern University under Dr. Anthony Schaeffer.
I see timberdoodle's trial is at a different place. Apparently there are many locations where this trial is being done.

I would have to drive 6 hours one way to Chicago for several weeks for this. I don't know if it is worth it especially if I am part of the 1/3 who gets the placebo. I also worry about side effects and being a guinea pig.
Perhaps I wait until the results of these trials come out.
If they are positive, I could always ask my GP for the drug.

I also wonder what other members on this site who have tried this drug thought. I know some have, but the reviews are few and mixed.
Gifford

[timberdoodle]

I finished up the first two weeks of the trial. The initial dose was 50mg 3x/day for a 150mg/day total. If I was on the drug, I didn't realize any improvement at this dosage. I started out the first three days or so feeling great and then had a significant flare that was as bad as anything I've experienced recently, which has now mellowed out down to normal again.

I've started the second dosage now, which is 100mg 3X/day for a total of 300mg/day. I'll report back on any improvement or lack of improvements at the final change in two weeks, which will be to the maximum dosage (600mg/day).

[timberdoodle]

I began the final phase of the trial a couple of days ago. I have now bumped up to the maximum dose (600mg/day or 200/mg 3X/day) of the drug. I do believe that I'm on the drug given the fact that I was somewhat spaced out on the day I began the maximum dose.

If I'm not on the drug then the placebo effect is stronger than I ever imagined!

I didn't have any side-effects in the middle dosage (300mg/day) for the two weeks I was on it. I did feel like my symptoms improved on the 300mg/day dose. I only had one day that my symptoms really bothered me. Otherwise, they were pretty low-key. It wasn't like I was totally healed, but they were certainly in the background and off my mind.

I'll report back in two weeks after the last phase of the trial. There is also the option to continue for another six weeks on the maximum dose after the trial ends. I'm not sure yet if I will continue. We'll see how it goes.

[timberdoodle]

I finished up the first phase of the trial this past week. I had a strange experience on the high dose period: my symptoms returned more forcefuly and I felt a bit loopy, so I backed off to the middle dose (300 mg/day) and felt better again.

I would say that the 300mg/day mark has helped lessen symptoms. I decided to continue the trial for another six weeks, staying at this middle dosage (I was mistaken in an earlier post when I thought the 2nd phase of the trial called for the high dose only).

Hopefuly the next six weeks on a consistent dosage will enable me to see more clearly the effects of the drug. Overall, I would say that it has helped with pretty minimal side effects. The problem will be whether or not my body adjusts to the medicine and the symptoms return (that happened to me with Elavil in the past).

I'll post back later with more developments...

[BilleyeDoc]

Can you tell me how you are doing and if u went to 600mg. I am on 300/day and I believe that I may feel better

[timberdoodle]

I did go to 600mg/day for about 10 days. I began to feel worse on this dose than I did on 300mg/day. I switched back to 300mg, and that is the dose I am currently on.

As part of the study I will be on 300mg/day for about 4-5 more weeks, which will give me a pretty good sense of whether or not the drug will help me.

Right now, I would say it's helping some but not having the amazing effect I might have hoped for (as described by a fellow from England who emailed in. See topic: viewtopic.php?t=3231)

Are you involved in the study, or were you able to get a prescription from your doctor?

[MB]

I have tried so many of those drugs. They work for a while then they totally stop when your body adjusts.
They make you lethargic and affect your balance and memory. I wonder if the placebo they use makes you sleepy also because it would be trivial to realize if you are on the real thing or not.