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.

Why brain surgery first?
 

Just reviewing the info out there on clinical trials and use of this treatment. I was surprised to find that this delivery system is given only afterDBS has been eliminated as a possibility for the patient. OK, I get that a pump infusion system requires surgery and is invasive, but we're supposed to try brain surgery first? Hmmm...guess I don't see how giving someone free reign with wires inside my head is less invasive than installing a pump through my small intestine.

Also, why the exorbitant cost? I think both research and clinicians agree that smaller, steady doses of levodopa is actually better for us as it mimics natural processes vs. the nasty on-off effects and dyskinesia. Why wouldn't this therapy be offered as an alternative to DBS? I don't understand why you would need be ready to enter into a nursing home to be eligible. It seems to me that Solvay is missing an opportunity to market this differently, or are there simply too many complications wherein people cannot tolerate the treatment?

Laura

Good points Laura ...
 

I believe the reason it has been considered for pwp about to enter a nursing home is that the cost benefit of Duodopa versus nursing home is easier to argue.

I cannot understand why the drugs are so expensive, l-dopa is pretty cheap, liquid l-dopa aka Duodopa seems to cost "$ large". Is this an example of a company pricing themselves out of the market ?

Why it should be considered only after dbs is a mystery to me. I agree I would take nearly anything over brain surgery. :( I wonder if there is a vested interest lobby for dbs among companies and Neuros who perform dbs !!

To me this highlights the struggle to get drugs to market. We go through a never ending round of trials possibly only to find the company's pricing model is off the pace due to the costs of drug delivery to market. Then we have to lobby the medical profession to move away from their existing pet company / product to consider the new alternative.

Makes you wonder how anything for PD gets to market (oh hang on, thats probably why nothing has for 40 years). I wish I had more answers.

Take care,
Neil.

duodopa AFTER DBS @@!??
 

Why can't the duodopa be approved instead of the brain surgery?

They drilled my head and I'm still taking 1500 mg of levodopa a day! I'd much rather have the pump!! And why the heck is this treatment which is so effective being squandered on those in nursing homes! Think of those that this could help get back on their feet and be productive with a lot of life ahead of them, NOPE I cannot see how this is more expensive than brain surgery-perhaps in the long run (drug costs,etc) but come on, initially?? I smell a rat!! I'm up way too late and tommorrrow is another day. Let''''s face it this healthcare thing is never going to be fixed. It's too dollar hungry with special interests. Nite ya'll.

screening for duodopa trials
 

I will start screening for trials aat Cleveland Clinic (OH) this month

MCG in Augusta GA clinical trials
 

My husband is one of two who have participated in the open label trial at Medical College of Geogia in Augusta. He underwent surgery in September, 2009. Had the reported infection at PEG site - very severe. Had to have additional surgery to remove infection and properly place the peg. Duodopa is great. Much less fluctuation and much less dykenisia.

Problems with peg
 

My husband is participating in the Duodopa trial at MCG in Augusta, GA. He had the surgery in September 09 and did have the problem with leaking at the peg site which did lead to a very serious infection and he became septic. He was in the hospital for 24 days. We almost lost him. The drug works great but he is still struggling to regain his weight and strength after the long hospital stay.

It is my understanding the pegs and tubing are different from the pegs and tubing normally used in the US. Our doctors agreed that Solvay should either change the pegs and tubes or train our US gastro doctors about the differences. It seems like a simple solution but I continue to hear of these same problems again and again. If they know there is a problem, why don't they just address it??!! It is so frustrating.

My husband has had great success with Duodopa. The continuous infusion has greatly reduced his fluctuations and dykenesias. I just pray that get this approved quickly because we can surely see the great benefit it would be to so many people suffering with PD.

[QUOTE=Stitcher;566120]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.



Unfortunately I don't believe the problem has been resolved. There is a problem with our surgeons being unfamiliar with the different peg and tubing and apparently Solvay has been slow to either change the tubing or further train our doctors. My husband is in the study and had surgery in September 09 to insert his peg. He got a serious infection, requiring additional surgery to repair and correctly place the peg along with removing the infection. He became septic and came very close to dying. He was in the hospital for 3 1/2 weeks. The drug is great but the procedure needs to be perfected. Seems that the solution is simple -- but Solvay hasn't responded very well.

Why are they so indifferent?
 

[QUOTE=Dianne G;622585]Thank you so much for this valuable information. It is upsetting that Solvay does not see the immense marketing opportunity in its system. If it could work out the kinks, and perfect the tubing mechanism and get a handle on cost, they could have a potentially huge market for those who need more continuous dopamine delivery (that is the majority of us at some point). This could really be either an intermediary treatment between meds and DBS or an viable altemative to DBS. I wonder why they do not "get this"?

Sorry to hear that your husband ended up with such a serious reaction and infection. I am glad to hear that he has rebound and gains benefit from the system. Will he be able to continue treatment after the trials are over?

Laura

Duodopa study
 

[QUOTE=Dianne G;622585]Thanks for the information: My wife is to start a clinical trial with this on the 22'nd of Feb 2010, next week. I will ask if the tubing has been changed or if the problems still exist. I would hope that the problem has been corrected. She currently has a lot of off time and we are looking forward to an improvement without the DBS. Will let you know next week how it goes.
Thanks again
Cmeender

just getting caught up
 

i'm just reading this thread - got behind. Thanks for all the information from trial participants and family. I hadn't heard about it only being used if a DBS is ruled out.
Dianne, i'm so glad it was all worth it! what a nightmare.....

cmeender, wishing you all the best.

the drug companies sink to new levels all the time. They put you through the ringer and completely disregard the punishment and emotional/psychological consequences of the trauma, let alone the near death experiences.

after all that, it better work!
please keep us posted.
paula

Chris 49 UK. PD for 15 years, Duodopa since December 08.
 

From my personal experience, I continue to have a small amount of moisture, but I shower every day, I was also treated by local nurses who kept a watchful eye on me for few months. Now I am back to swimming to keep fit. Try to keep life at a manageable pace. Yes this is a new way of treating my parkinson's symptoms. But the medication isn't.Everyone of us are different, with our own responses to treatments. For my part a tube through the stomach is the last thing to worry about, pre Duodopa I was on the floor or on my bed, off, rigid etc This I refer to as the darkside of my PD. Hope this helps.

a sincere thanks
 

I am soooo appreciative for the trial participants comments here. Those of you directly involved can help to dispel some of the endless speculation that comes from not having enough information , and hopefully learn from each other quickly.

welcome to all trial participants,
paula

thank you..
 

Thank you Diane for your information. This brings to mind IF Stolvay is even aware of the problem. They may be attributing this to post-operative infections, staff not being familiar with the device, monitoring it, etc. Think how hard it is for a PD patient to be admitted to the hospital for a non-PD related reason and JUST try to stay regular on your meds! They can't do it!

Duodopa study
 

My wife is currently in a duodopa study and is the first at the hospital doing the trial. She started on the 22'nd of Feb 2010 and is doing very well on the medication. The only issue she had is the tube pulled out once the first week and had to be put back in. Since then it has been going well. The great thing about it is no ups and downs. She is on all day long now which is great and rarely has any dyskinesia. The downside is the size of the pump and we do not know the cost at the end of the trial. Definitely would not like going back to taking pills every three hours or so and then getting dyskinesia as well.
She had some discomfort to start with because of the tube but that has been resolved and she is no longer on pain medication. We are still looking for better ways to carry the pump as the shoulder strap is cumbersome and she would like it to be somewhat concealed. If anyone has a good idea please let me know. The pump is 8 inches long 4 inches wide and 1 inch thick.
Have a great weekend.
Cal

Possibilities
 

Cal,

Thanks for reporting back on this; it is encouraging to hear how well others are doing with this method. It is far superior to the oral delivery and is a long overdue alternative to brain surgery. Please keep us informed as to the pricing as it may apply in a long term use basis; I fear that Solvay may price it out of reach for many people.

Cal, do you know if it is mandatory that the pump unit (box) be carried upright over the shoulder like a handbag? I love to sew, so sewing ideas quickly come to mind. If the shoulder is not necessary, you might be able to find someone to make a custom fanny pack where it is secured around the lower waist or upper hip...almost like a belt. The other idea is to have someone create a little undergarment with an inside/hidden pocket that secures the pump while concealing it. The other idea is, if you can't hide it, flaunt it. There are many beautiful fabrics that we like; she could have a few "designer" bags made to liven things up a bit. Lots of possibilities.

I hope your wife continues to do well and feel better.

Laura

Cost of Duodopa
 

Chris and others who are in clinical trilas or treated with Duodopa, can you share with us info on costs for this treatment and how readily it is prescribed?
I have heard rumors that Solvay (now Abbott) was treating this as an end phase, nursing home bed, last resort treatment due to high maintenance costs. Yet on their web site they show active people and tout how it really gives patients a sense of freedom; a far cry from withholding treatment until end stage disease. Other rumor is that the pump will only be considered by doctors in patients who do not meet criteria for DBS...in other words, brain surgery would be the preferred course of pump inusion!? This has never mad any sense to me. Anyway, I would greatly appreciate if anyone could clarify any of this!

Laura

Sounds like the Pump is the size of a cellphone
 

I have the pump
 

I have been in the study since March 2009. I live in Ohio and just wanted to jump in and say that this system really works! I noticed that there seems to be some concern about infection at the port site. I have had little problem with this. A port is a port. Simply keeping the site clean and not snagging your port on something and jerking it are the two most important items. I am now in the second year of treatment. I was not in a blind study. I got the drug from the first. I only have to see my neurologist every six months and life is great.

Dan

Update:

My husband continues to do well with his duodopa trial study. He has to go in every six weeks for a check-up and to receive his meds. This new drug is great. He has regained his strength and most of his weight - and is generally doing much better than before. When he is on, he has no signs of PD. An occasional off time occurs, but rarely. The duodopa has been great!!

Hi, I'm new to this forum so please forgive me if I write things that are already known. I just wanted to say that in Sweden, where I live, there are about 200 persons with PD (out of about 20 000 with PD) treated with duodopa-pump. The cost is about $140 a day.
I know a man in his mid-40's who literally got his life back when he started treatment with the pump. He went from very disabled to working fulltime travelling alot in work.

Sara

My husband has the pump. We modified a heavy-weight t-shirt by putting a pocket on the front just large enough for the pump to fit, with velcro at the top to close it, cut a hole through the back of the t-shirt for the tube to fit in. We just pull the tube through the hole and out of the pocket, then attach the pump, and drop the pump into the pocket, and seal the velcro (this prevents the pump from falling out when he bends over). Then he wears his normal shirt over the t-shirt. Maybe she can use some variation of this idea to suit her specific needs.

Duodopa trial in Milwaukee
 

Hello,
We are new to Neurotalk. Dan is scheduled to start the open label Duodopa trial at Froedtert in Milwaukee next week. We wanted to touch base with you, share your experiences before and after the surgery. We are from Minnesota but will be traveling to Wisconsin (often for the first several months) or staying in town if need be. We would love to meet you both while we are there.
Dan & Arlene


[QUOTE=cmeender;623604]

[QUOTE=lute;683318]Hello,
We are new to Neurotalk. Dan is scheduled to start the open label Duodopa trial at Froedtert in Milwaukee next week. We wanted to touch base with you, share your experiences before and after the surgery. We are from Minnesota but will be traveling to Wisconsin (often for the first several months) or staying in town if need be. We would love to meet you both while we are there.
Dan & Arlene

Duo-dopa study
 

[QUOTE=lute;683318]Hello,
We are new to Neurotalk. Dan is scheduled to start the open label Duodopa trial at Froedtert in Milwaukee next week. We wanted to touch base with you, share your experiences before and after the surgery. We are from Minnesota but will be traveling to Wisconsin (often for the first several months) or staying in town if need be. We would love to meet you both while we are there.
Dan & Arlene

Hi Dan and Arlene: I am not sure how to give you information to get in touch with us. We live in Racine which is just south of Milwaukee. We are about 35 minutes from Froedert depending on traffic. My sign in is part of my first name and part of my last name. Add ing to the end of the sign in and separate the first letter. Good luck next week; I can tell you the nurses on the fifth floor at Froedert are great, very helpful and will take very good care of you. Hi to Jennifer, Julie and Ashley.
Cal & Nancy

Hi Diane: The T shirt idea sounds great; I will have to ask our daughter to try to make one. Currently Nancy has a shoulder holster similar to a gun holster but designed specifically for the pump and it works better than the one they originally gave us. Our daughter also made a fanny pack that is very light but my wife prefers the holster.
Cal

contact information
 

Dan: My wife is currently on the study at Froedert; If you wish to contact us try calling our daughter at her business Racine Community Acupuncture.
Just Google it and it will come up first page.
Our best wishes this week.
Cal Meendering

[QUOTE=lute;683318]Hello,
We are new to Neurotalk. Dan is scheduled to start the open label Duodopa trial at Froedtert in Milwaukee next week. We wanted to touch base with you, share your experiences before and after the surgery. We are from Minnesota but will be traveling to Wisconsin (often for the first several months) or staying in town if need be. We would love to meet you both while we are there.
Dan & Arlene

Duodopa trial in Milwaukee
 

Hi Cal & Nancy,
Well, we did it!! Dan & I travelled to Milwaukee for the duodopa clinical trial - open label. We are back home in Minneapolis, trying to get used to the dosing regimen and to finding a comfortable way for Dan to carry around the pump. We'd love to share your experiences with both. Our next appt at Froedtert is Sept. 20th. We will try to reach you through your daughter's business.

Dan & Arlene Lutenegger

[QUOTE=cmeender;687209]Dan: My wife is currently on the study at Froedert; If you wish to contact us try calling our daughter at her business Racine Community Acupuncture.
Just Google it and it will come up first page.
Our best wishes this week.
Cal Meendering

Has anyone in the duodopa trial had DBS?
 

I was wondering about this. I have been trying to get into this clinical trial but have not heard back from the sites that I have e-mailed to express my interest. I've had DBS but it was less than optimal results. I was told that my leads were marginal. Still having to take about 10-12 levodopa a day. Thanks

Carry the pump easily...
 

I have had the pump for 14 months. I have a great way to carry the pump. call me **

[QUOTE=lute;692300]Hi Cal & Nancy,
Well, we did it!! Dan & I travelled to Milwaukee for the duodopa clinical trial - open label. We are back home in Minneapolis, trying to get used to the dosing regimen and to finding a comfortable way for Dan to carry around the pump. We'd love to share your experiences with both. Our next appt at Froedtert is Sept. 20th. We will try to reach you through your daughter's business.

Dan & Arlene Lutenegger

I have had the pump for 14 months.
 

The duodopa study has been a God send for me. I've had it for 14 months and without it I can't walk or take care of myself. With it, most people don't know I have PD. The reported problems with the PEG site that I read here are false. It is easy to care for and I've had no problems. Reply with questions and I'll try to answer them. Also I found a great way to carry the pump....

RD