Anyone know how Duodopa is going?
 

I've heard of a lot of problems with leaking at the peg tube site leading to infection. Not much else though. UF has it on their site that the study they are doing is scheduled to end mid 2010.

I had a doc from the University of South Florida, Tampa, say that there were a lot of issues with infection at the site. I can only hope that this problem has been resolved.

http://neurotalk.psychcentral.com/thread11120.html

What's Europe's Secret?
 

Duodopa has been used, quite successfully I understand, for four years now in 12 European countries. The Swedish have perfected the pump system, and the concept of an infusion was tested back in the 80's- this is hardly a new ideal.

From NPF:

Twenty-one years later, the medication called duodopa, administered into an area of the small intestine called the duodenum, is still in clinical trial in the United States.

What is annoying is that it's taken over 20 years for a pharamaceutical company to actually develop this therapy. I suspect it's because pharma didn't think this would compete with oral Sinemet, despite the evidence that a continuous infusion greatly reduces dyskinesia and on/off effects- really it's better for us over all. Now that Solvay sees a market in this treatment, I'm guessing it's the FDA bureaucracy holding things up? Anyone know the story behind this treatment?

Laura

Never mind....
 

Never mind. Clinical trials once again use the fail proof placebo control; we'll be lucky if duodopa bounces over to MJFF for further research and tinkering before it ends up back on the FDA "fast track"- anyone got another 21 years to spare?

-L

What gives???
 

Hey , where did you hear that about the placebo?? I cant imagine it being so. You're getting the drug straight into your system it has to be better!!!!
WTF .. when are we going to get something that will give us some damn help and stop all this marketing ******** if they've had this therapy for 20+ yrs why wont it work for us?
F@@@@ Dumb A@@. Go ahead and censor me:mad: :mad:

Jim,

Sorry if I confused. It's just that placebo control research is highly suspect any more given the results of the Ceregene trials. They're finding that PWP are highly susceptible to placebo effect (given that it's linked to dopamine centers in brain may have a little something to do with it). I figure that with Duodopa also undergoing placebo controls, there may be problems- this is sarcasm- I don't know that there actually is a problem at this point.

It is true; however, that this therapy was conceived of by pharma researchers over twenty years ago, and that the infusion pump is successful in Europe for at least four years. Why, then, would it be a problem for the FDA to approve it here?

Laura

first 4 patients open label at u of alabama
 

the university of alabama is doing a duodopa trial with the first four people open label. so the first 4 are getting the drug for sure. the rest is blinded. i don't know if all centers are doing open label and blinded. if not, that would justify the travel to alabama i have been told the first surgery , open label, went very well.. that leaves 3 more open label to go ....at alabama, so ask the other centers if you call about it.

let us know if there are others doing open label will you please?


thank you,
paula

just don't understand this...
 

Surely these are known drugs, (Levadopa), why years of research and "blind testing".

God, this situation stinks when we wait years for a different delivery mechanism for a 40 year old drug to be tested.

Why not provide Duodopa to all, today, whats the worst that can happen.

I will attempt to provide an update on UK status following my neuro meeting 11/09.

Neil.

'THOU SHALT NOT APPROVE DRUG iN TRIAL WITHOUT PLACEBO" , sayeth the FDA and most of the other medical profession in the USA.

thanks neil, for letting us know how the real world is doing with this.

paula

Paula I spoke to my Neuro and he said ...
 

Duodopa is cleared as a treatment in the UK. It is very expensive though, $60k dollars a year for the drugs alone, then add in the aftercare, monitoring etc and add on $150k. So tough to justify however the PWP it has treated tend to be those about to go into a nursing home where Duodopa becomes cost effective versus the cost of the home. Apparently if being considered by a Neuro, Duodopa "makers" bring their own Accountant to meetings !!

Still looks very effective end stage treatment according to the Neuro.

Hope this helps,
Neil.