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-   -   Abbvie still enrolling for Duodopa study (https://www.neurotalk.org/parkinson-s-disease/204711-abbvie-enrolling-duodopa-study.html)

Conductor71 05-20-2014 05:38 PM
Abbvie still enrolling for Duodopa study
 
I was quite surprised to learn this given that they have applied for FDA review, but they are indeed still enrolling for phase 3 open label trials. The kicker is that the limit is for 38 participants and takes place in only a few states: CA, WA, IL, MI.

I am fortunate enough to have a study going on less than 50 miles from my home. I already have a tentative date of July 2nd for the procedure.


I know that some are skeptical, but I think this might be a really great opportunity for a less invasive surgery than DBS. There are many benefits:

proven therapy that works (efficacy in high 90th percentile)
longitudinal evidence it is relatively safe
benefit of 16 hours continuous "on time"
less dyskinesia
minimally invasive 45 min. procedure (home in 2 hours local anesthetic only)
free ride on expensive drug for a minimum of 15 months

I already have the procedure tentatively scheduled for July 2nd! I go in for my first screening appt in early June.

I hope I make the cut. If there is interest I will share more info if it looks like it is all systems go for me.

Laura

link to study info: https://www.clinicalconnection.com/19726.aspx

john1947 05-20-2014 06:09 PM
reply
 
Quote:
Originally Posted by Conductor71 (Post 1070592)
I was quite surprised to learn this given that they have applied for FDA review, but they are indeed still enrolling for phase 3 open label trials. The kicker is that the limit is for 38 participants and takes place in only a few states: CA, WA, IL, MI.

I am fortunate enough to have a study going on less than 50 miles from my home. I already have a tentative date of July 2nd for the procedure.


I know that some are skeptical, but I think this might be a really great opportunity for a less invasive surgery than DBS. There are many benefits:

proven therapy that works (efficacy in high 90th percentile)
longitudinal evidence it is relatively safe
benefit of 16 hours continuous "on time"
less dyskinesiaHi laura,
I hope you get to try the pump.What bothers me is the foot draging.The pump has been on the market along time so i wonder why trials are needed.
I have a friend who has advanced PD. He spends most of his time in bed.The place hes at(VA hosptial)sort of gave up on him ,very litle therapy. hes 70 and not demented so i wish he could get a chance at the pump.he should have had a shot at DBS but didnt.
They say most dont qualify for DBS but they dont say why.
Hope all goes well and you get relief.
I also have tried to get info on the trials but havnt found any literature on them.
best
john
best wishes on your trial.
minimally invasive 45 min. procedure (home in 2 hours local anesthetic only)
free ride on expensive drug for a minimum of 15 months

I already have the procedure tentatively scheduled for July 2nd! I go in for my first screening appt in early June.

I hope I make the cut. If there is interest I will share more info if it looks like it is all systems go for me.

Laura

link to study info: https://www.clinicalconnection.com/19726.aspx
good luck ,john

Tupelo3 05-20-2014 07:16 PM
Best of luck with this Laura! Keep us informed.

Gary

RLSmi 05-22-2014 09:48 PM
Laura, good to hear from you again. Best wishes for inclusion and success with Duodopa.

Robert

lindylanka 05-27-2014 03:11 AM
Quote:
Originally Posted by Conductor71 (Post 1070592)
I was quite surprised to learn this given that they have applied for FDA review, but they are indeed still enrolling for phase 3 open label trials. The kicker is that the limit is for 38 participants and takes place in only a few states: CA, WA, IL, MI.

I am fortunate enough to have a study going on less than 50 miles from my home. I already have a tentative date of July 2nd for the procedure.


I know that some are skeptical, but I think this might be a really great opportunity for a less invasive surgery than DBS. There are many benefits:

proven therapy that works (efficacy in high 90th percentile)
longitudinal evidence it is relatively safe
benefit of 16 hours continuous "on time"
less dyskinesia
minimally invasive 45 min. procedure (home in 2 hours local anesthetic only)
free ride on expensive drug for a minimum of 15 months

I already have the procedure tentatively scheduled for July 2nd! I go in for my first screening appt in early June.

I hope I make the cut. If there is interest I will share more info if it looks like it is all systems go for me.

Laura

link to study info: https://www.clinicalconnection.com/19726.aspx
Best wishes with this, Laura, hope it brings what you need.

Conductor71 06-24-2014 05:58 PM
Quote:
Originally Posted by lindylanka (Post 1071862)
Best wishes with this, Laura, hope it brings what you need.
I just wanted to update all of you because I almost didn't meet the criteria due to low vitamin B12 level! I bring this up because we have talked extensively here about low B vitamins. In my case, this is the first I have tested deficient in the B range. I wonder if it has to do with high levodopa dosage that I take? I plan on asking my doctor why my B levels matter at all for this treatment. Maybe this will shed some light on our previous discussion?

As for the surgery, I have the tube implanted on July 2nd and will have med started up on July 8th. Oddly, the surgery will take 45 minutes and the drug titration 6-8 hours. I will let you know how it works; from what I have read it also helps nonmotor symptoms.

I'm not sure I reported this before, but the treatment is around $30,000 annually in Europe; there, PWP are considered for three options: DBS, Apomorphine pump, and Duodopa pump. Contrary to what we have rea

Even more interesting is that a trial is starting for a subcutaneous levodopa pump this winter. My doctor informed me that I may be able to switch out into that trial; that would be scads less cumbersome were it to work!

If anyone has any questions, I will gladly check with the lead researcher.

Oh one last tidbit. The Duodopa pump has been in trial since 2000 in the US! This means there are people who have been on it for 14 years and are still on it with no adverse effects. Unbelievable that it is taking this long...

Laura

Tupelo3 06-24-2014 08:28 PM
Quote:
Originally Posted by Conductor71 (Post 1077905)

Even more interesting is that a trial is starting for a subcutaneous levodopa pump this winter. My doctor informed me that I may be able to switch out into that trial; that would be scads less cumbersome were it to work!

If anyone has any questions, I will gladly check with the lead researcher.

Oh one last tidbit. The Duodopa pump has been in trial since 2000 in the US! This means there are people who have been on it for 14 years and are still on it with no adverse effects. Unbelievable that it is taking this long...
Laura, with all of your knowledge and the research that you do, I'm sure you'll make the right decision for yourself.

Regarding the subcutaneous pump, I'm aware of two different companies researching this. I've seen presentations by both and have spoken with the CEOs and research teams, and they are quite interesting. I believe the one you are referring too would be Neuroderm, the Israeli company developing a L/C pump-patch. The product is really amazing. It's smaller than a credit card, has a reservoir and delivers the drug via a series of micro-needles. They are beginning a Phase II study soon. The Phase I safety and tolerability results were great and they showed steady levodopa blood plasma levels. Some wall street VCs I know think this could be a blockbuster. Of course, it's several years away from possible approvals, so it may be worth looking into the trial if possible.

Best of luck with whatever route you take!!

soccertese 06-25-2014 08:10 AM
i'm looking forward to inhaled l-dopa
 
i think it offers the potential for more even blood concentrations of l-dopa.

i have to hope that inhaled l-dopa, in phase 2 testing i think, might be another alternative in that it also completely skips the digestive system which i think duodopa strangely doesn't, it delivers the l-dopa to the intestine. it would likely be too expensive to take as your primary drug but more advanced pd'ers could possibly take less oral meds and not have to worry about wearing off as much. afternoons and evenings are where i have the most variability in my l-dopa response, probably partly due to protein interference, maybe l-dopa nerve receptor overstimulation?, but regardless, quick acting inhaled l-dopa should improve the quality of life and give you the luxury of having a more steady dose of l-dopa? easy to intellectualize this but the cost of the l-dopa gel for both of these external devices is incredible and i have to wonder just how many insurance companies will pay for it. it's that recurring cost. healthcare costs are going up again and with obamacare funding so much medicaid and other private policies, and increasing medicare costs, cost cutting has to occur somewhere.

but if i was in your shoes laura, i'd want anything that helps.

Jim091866 06-25-2014 12:33 PM
I wonder if they are doing anything different.
 
I wonder if they are doing anything different like a new type of port for the tube since a major complication was tube being dislodged.




Quote:
Originally Posted by Conductor71 (Post 1070592)
I was quite surprised to learn this given that they have applied for FDA review, but they are indeed still enrolling for phase 3 open label trials. The kicker is that the limit is for 38 participants and takes place in only a few states: CA, WA, IL, MI.

I am fortunate enough to have a study going on less than 50 miles from my home. I already have a tentative date of July 2nd for the procedure.


I know that some are skeptical, but I think this might be a really great opportunity for a less invasive surgery than DBS. There are many benefits:

proven therapy that works (efficacy in high 90th percentile)
longitudinal evidence it is relatively safe
benefit of 16 hours continuous "on time"
less dyskinesia
minimally invasive 45 min. procedure (home in 2 hours local anesthetic only)
free ride on expensive drug for a minimum of 15 months

I already have the procedure tentatively scheduled for July 2nd! I go in for my first screening appt in early June.

I hope I make the cut. If there is interest I will share more info if it looks like it is all systems go for me.

Laura

link to study info: https://www.clinicalconnection.com/19726.aspx

Lemonlime 06-26-2014 12:33 AM
Good Luck Laura!
 
Best of luck, Laura! Will keep you in my prayers! My neighbor that works for Abbvie is under a non disclosure clause and couldn't give me a lot of information. He did say that patients were having amazing results! 😊 Keep us posted!


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