Most everyone here probably knows that trials for these three candidates are set to begin soon...Ceregene's new trial begins August of 2010, next month, cogane is set for early 2011 (I assume first quarter) and gdnf, also sometime in 2011.

We met with our neuro this month who again would like us to seriously consider doing the Ceregene trial...we are only four years into this and understandably very nervous about participating in a trial like this. Since we are early onset and in otherwise excellent health (other than those few extra twenty pounds, thanks to the mirapex), we represent a probably rather unusual, but medically compelling, candidate for PD brain surgery. We appreciate that, and also the contribution we could make to research by going forward with such a trial...

But, and there are many buts, we have very young kids. This is huge for us. And another but, half of the participants in the trial will be sham surgery....who will only be offered Neurturin IF it is deemed safe and effective, AFTER the trial ends, in two years.

Our worst fear, and it is very real: we agree to do the trial, get into the sham surgery group, spend two years waiting for the trial to end, it is deemed either not safe or effective, and the drug withdrawn. We then have waited two years, had sham brain surgery, do not get to have any Neurturin, and are disqualified from being in any other trial. We will have had PD for only 6 years at that time.

Another option is Cogane, which our neuro said his facility will be involved with as well, and that trial is coming up in six months or so. We are really not able to find out very much about Cogane, and while our neuro did not really say anything about it, he did not seem very excited about it. Perhaps he, like us, has not been able to find out much about it. Yes, we have read all the hoopla everyone else has, but that's all it has been. We have yet to see hard and fast data, statistics, or any analysis of the Phase I trial that has taken place. Anyone have that and is willing to share, we'd really appreciate it. Obviously, we would prefer participating in a promising trial that involves taking a pill over having any kind of head surgery...sham or otherwise.

And then there is GDNF...who knows what type of candidate they are looking for with this trial...or whether we would even fit that criteria.

We realize many here have been grappling with PD for a decade or more, and we are early in the game, as they say. Does anyone have any thoughts about which trial, if any, might be best or better for a PDer at our stage, with little kids, and circumstances? What would those reading this do, if you had the choice to participate in one of these three trials?

In defense of the Ceregene trial, our neuro did say that while the earlier trial did not meet the primary endpoints, something like 24 out of 27 secondary endpoints were met, and several of the participants "looked really good", for what that is worth. It's compelling, and on those days when you have a really bad day, or several bad days in a row...brain surgery doesnt' seem such a bad idea.

Any thoughts, comments, we'd like to hear them all. I am grateful we at least have the issue before all of us, which is, golly, which trial would I like to try to participate in, as opposed to having no trials going on at all, or only trials for yet another agonist or levodopa formulation. That is something, albeit an enormously difficult decision.

Good questions, all. The Cogane trial is looking for 'de novo' patients only - early diagnosed NOT on meds yet. I wrote them and asked. If I fit the criteria, I'd jump at the chance for this one.

But I am not eligible for Cogane, so I'll see if I'm eligible for the GDNF trial.

As far as sham surgery - in the Ceregene trial, my thoughts: In principle i'm opposed to sham surgery, but am coming to see it as a 'necessary evil' for pwp if they have any intention of ever participating in US clinical trials. For pwp who refuse to participate in any trial with sham, this is not an issue.

If you get sham surgery:

1. if the trial fails, you haven't had invasive brain surgery
2. if it succeeds, you wait 2 years for the real treatment - BUT this will still be years ahead of the rest of pwp in the US waiting for FDA approval of a new treatment (plus waiting for approval of health care companies to approve payments for new brain surgery treatment)

Good luck to you,

Jean

Are there guarantees that you will receive the real thing at trial end if it is successful and meets end points, and you were a 'sham' recipient?

Given that you have a young family Cogane would seem a good option, non-invasive.

My brother-in-law who lectured on OT practice for many years always said that no operation is without risks, not even the simplest ones.

Is life is manageable at the moment, enough to wait some more........

there's also a likely neurologix phase 3 coming up and isn't oxford biopharma or something like that showing good results? i think more than 3 options in the pipeline.
and more entering soon.
i don't understand what "looking good" means. did your neuro actually see those patients and if so was he wearing rose colored glasses? i'd also closely check out their other clinical trial outcomes. and i'd closely study ceregene's phase2 results and ask if the affects are still lasting and even ask to talk to a few subjects.

i'd say young children makes it a bad decision, too much at risk to be a guinea pig unless phase2 had terrific results. when the right time comes, you'll not have any doubts.
none of my business but have you tried the long lasting requip?

Yes, this neuro actually switched off us mirapex to requip and what a total disaster that was, we had to go back to mirapex unfortunately. The requip had no effect for us at all...we did a ton of research on this and it is actually amazing to me that two drugs have such vastly different responses in people. How can that be? A drug makes someone's life manageable for one, yet miserable and worthless for another. Crazy.

We did, this last go around, get a sample for mirapex extended release...I'm going to post about that under another thread so folks can see it if they are interested.

We are keeping up with Oxford Biomedica (prosavin) but that's in Europe and I sort of see that as a longer shot...and yes, there are other things in the pipeline too but these three are sort of in our face. I guess we can forget about Cogane since they are looking for PWP not on meds, that may be hard to find or at least take longer to find.

Thanks for your input. I meant to PM you and let you know I really appreciate and like your posts....you tell it like you see it and I respect that.

If it's so stated in the Consent form - you have a good chance they will keep their word...

jean

They are metabolized very differently - one in the liver and one in the kidneys (I can never remember which one is which) I had a clinical trial doctor (an MDS at a nationally known site) deny this - but I have never decided if (1) he were just stupid and didn't know his facts or (2) he hated it when patients searched the internet and came to him with their own questions & opinions. At this point, I'm leaning toward #2.

and so it goes... Jean

responded the same to regular mirapex/requip, requip incapacitated me, could barely tolerate .125mg mirapex so settled on sinemet. will be very interested in your extended release mirapex experience.

there's this trial:
A Multicenter, Randomized, Double-Blind,Placebo-Controlled, 5-Arm, Parallel-Group Trial To Assess Rotigotine Transdermal System Dose Response In Subjects With Advanced-Stage Parkinson's Disease

Description
The primary objective of this trial is to show rotigotine dose response (at 2, 4, 6, or 8mg/24h) in subjects with advanced-stage Parkinson's disease. A secondary objective is to demonstrate the safety and tolerability of rotigotine at these doses.

Currently Enrolling

Who Can Participate?
Patients who are at least 30 years of age and with a diagnosis of idiopathic Parkinson's disease, of more than 3 years duration, as defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism.

Investigator:
Alida Griffith, MD

For More Information:
Marsha Merrick 425.899.3115 MGMerrick@evergreenhealthcare.org
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looked up side affects for this agonist and skipped even applying.

lurking,
have you tried sinemet?

Yep, been on that for awhile, sigh...as well as a ton of other stuff (CoQ10, ALA, LDN, Dynacirc, Azilect, folic acid, etc. etc. etc.) Even grew our own fava beans this season, was kinda hit or miss, although we have ordered the fava bean juice from International Gourmet and are hoping it will extend the sinemet dose a bit. Someone here said it extended their sinemet three hours-wow!