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02-14-2011, 10:26 PM | #11 | ||
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It seems these claims are always overstated and based on rat data... for the very reason that most do not pan out to make it to human trials. On any given day, however, we all desperately need to believe something will work and we will live to benefit from it. So Debi, I appreciate your honest appraisal, but now hope you can tell us where MJFF thinks the cure will come from.
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02-14-2011, 11:38 PM | #12 | ||
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And I'd also like to ask: presuming that one of the many promising compounds/treatments pans out for humans in the next couple of years, what is the mechanism by which we can fasttrack it through the FDA? It seems like Parkinson's is not an urgent priority for them, because of its relatively slow progression, yet meanwhile people are losing their jobs, their independence and their quality of life.
MJFF and the work you guys do is our best hope, imho. But for those of us holding out for a non dopaminergic treatment, when will it happen? Do we have to wait three or four years or more for preladenant? And if its phase III is successful, what plan of attack do we have to get it to those who need it as quickly as possible? Last edited by caldeerster; 02-14-2011 at 11:50 PM. Reason: clarity |
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02-18-2011, 02:40 PM | #13 | ||
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In Remembrance
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from pipeline database:
http://apexutf.shellprompt.net/pls/apex/f?p=162:2:948399878974614::NO:2:P2_TREATMENT_NUM,P 2_RETURN_PAGE:921,12 from pipeline email: phase III now recruiting - this treatment was "fast tracked" by the FDA excerpts from Lancet Neurology: "In the trial, 253 patients were randomly assigned to receive 12 weeks of treatment with 1, 2, 5, or 10 mg preladenant twice per day, or placebo, and 246 received at least one dose of study treatment. The primary outcome was change in off time from baseline to end of treatment, assessed by home diaries. Reductions in daily off time were significant only in the 5 mg preladenant group, by 1·0 h, and the 10 mg preladenant group, by 1·2 h. Preladenant was not associated with any significant safety issues." also interesting is a Comment on the study, in the same issue, by William J Weiner and Stephen G Reich, "Another trial, another hour" A2A receptor antagonism is not a new idea: istradefylline, another A2A receptor antagonist, was tested in a similar clinical trial with a reduction in off time of 0·7 h.5 Despite istradefylline achieving so-called significance in clinical trials, the US Food and Drug Administration issued a not approvable letter expressing concern about the clinical usefulness of the drug.6 This response raises the important issue of clinical significance as opposed to statistical significance." "Clinical signifcance is not simply a notion of common sense, but has a well formulated methodology to establish minimally important differences for patients’ reported outcomes. In the past 5 years, this idea has received much attention in assessment of Parkinson’s disease and response of the disease to treatment.8,9 Hauser and colleagues cite another study by Hauser\and Auinger suggesting that a 1 hour reduction in off time per day might be the minimum clinically important difference in patients who have Parkinson’s disease and motor fluctuations." Numerous other problems with the study were noted.
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paula "Time is not neutral for those who have pd or for those who will get it." |
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02-18-2011, 07:45 PM | #14 | ||
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In Remembrance
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the scripps one is at the preclinical level what are we talking about then lol!
edited to add yes, we are talking about two different drugs - the information i posted is not the announcement substance from scripps. That has not been entered into the pipeline database yet. preladenant is entering phase III
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paula "Time is not neutral for those who have pd or for those who will get it." Last edited by paula_w; 02-18-2011 at 08:10 PM. |
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