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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 |
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Best of luck with this Laura! Keep us informed.
Gary |
Laura, good to hear from you again. Best wishes for inclusion and success with Duodopa.
Robert |
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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 |
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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!! |
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. |
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.
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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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Well enough, because the real adventure is the duo dopa, so here's hoping it becomes a good solution for you. Let us know how it goes. Xxx |
All the best Laura with the procedure.
The influence of levodopa and the COMT inhibitor on serum vitamin B12 and folate levels in Parkinson's disease patients. http://www.ncbi.nlm.nih.gov/pubmed/17565222 Replacement therapy for vitamin B12 deficiency: comparison between the sublingual and oral route. Cobalamin is traditionally administered by intramuscular injections. However, it has recently been shown [9] that the sublingual route is equally effective. In this prospective study of 30 subjects with vitamin B12 deficiency, we found that sublingual and oral administration of 500 µg of cobalamin was equally effective in correcting cobalamin concentrations. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1884303/ |
Thanks Lindy and Bog,
I am really glad to see your responses. I knew that long term levodopa treatment resulted in increase homocysteine levels and that this involved vita b levels, but I didn't fully grasp what this could mean until now. I knew this could increase risks of vascular problems including stroke, but I just now learned that high homocysteine levels also impact our metabolism of B12 resulting in deficiency. This in turn has now been linked to vascular dementia and may have a part in developing AD. This is clearly something we all need to be aware of. Interestingly, taking Entacapone helps to correct this imbalance, but in lieu of that it is imperative that I, or any of us who take higher doses of ldopa, supplement their B vitamin intake. At very least, we should all be checking our levels regularly. Laura |
Just wanted to wish you good luck, Laura! I hope all goes well for you. :)
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Those with low B12 levels need to be aware that there are several different routes to deficiency, and that oral supplementation does not work for everyone, and that test results are not always indicators of deficiency. As many symptoms of deficiency overlap with PD is important to note things we may have thought were 'going downhill fast' as PD mostly does not do this. The first signs of deficiency are very variable, for me it was tiny bleeds into the skin of my lower legs, called petechiae, and yellowish brown staining of the surrounding skin, due to plasma leakage, described as a later sign.
Two good sites are b12d.org, and the Pernicious Anaemia Society, also look for Sally Pachaloks book. This is not a condition to mess around with, by the time it shows you will have had it for some time. As you did with PD, take it seriously and do your research, because most doctors will not really be aware of the implications. B12d. Org has a poster you can download, which was presented in Paris this year. It has a lot of good basic information. |
Just to add, if you are taking higher doses of B12 you will need to take folate too, they are codependent. Just don't supplement with folate before investigating b12 deficiency, it totally masks it by reversing the macrocytic blood cells that are an indicator of deficiency.
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