More than 6 months ago in March, I wrote about the six-month random control trial of Pagoclone. The trial is the biggest ever outcome study for any treatment in stuttering, with 300 subjects controlling for placebo. I have also reported that the 300 places were rapidly filled up. Recordings are taken periodly within a six-month observation period, but this might be extended. So make your calculations: most subjects should have just completed their 6-month recording and the rest will in the coming weeks. Internally, they should already have replicated their Phase II study, with a 3-month observation and less than 100 subjects. The larger sample (and presumably better measurement standards) should give us more solid findings of the short-term effect. I would expect that all the data will be in by the end of the year, and add 3 more months for additional analysis, meetings and admin. So we are somewhere around March 2010 for a press release.
I have added the synthesis of Pagoclone above for all those of you who can't wait to try it out! ;-) And for those hoping for a cure solving all their problems, I suggest going for the standard illegal drugs, probably cocaine, ecstacy or cannabis for a good effect versus moderate side effects! Unfortunately, legal restrictions are preventing me from publishing the recipes...
Please those who are participating, let me know of your experience! Send an email to tom dot weidig to my gmail dot com.
9 comments:
Any idea when this medicine can be made public
I think anti-anxiety drugs for stutterers is similar to fluency shaping or stuttering modification practice. It's something you do to help you get to the point where you have proven to yourself that you can handle most speaking situations with ease. Like with speech practice, a drug can't be the only part in a therapy meant to last, but it may get you started on a positive spiral.
Here they write that trial will be finished in 2011:
http://www.clinicaltrials.gov/ct2/show/study/NCT00830154?term=stuttering&rank=1
Study Start Date: February 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure
A multicenter, randomized, 3-arm, placebo controlled, parallel group study with 24 weeks of double blind treatment followed by an 8 week double blind washout and then long-term open-label extension phase
Sounds like I am too optimistic.
But the trial was filled up very fast. And 24 weeks = 6*4 weeks. So we should be finished with the first phase for the majority of subjects. Plus 2 months washout. Then the data should be in by the end of the year at the latest? And then analysis. I still believe that March 2010 for the first results is realistic, but I could be wrong!
If a stutters base line stress level is a little higher than normal pagoclone may not achieve desired level of fluency. It might have to be pagoclone plus something else to really make a difference in some stutters.
Tom, I am currently participating in the trial and will be sending you an email on personal results. However, it is important to note that this trial not only tested the efficacy of the drug itself compared to the placebo but also tested the efficacy of different dosages ie., low, medium and high dosages.
Great. Please send me your experiences. Yes, I know that different dosages are being tested.
Today is August 20, 2011. Do you have any update on Pagoclone drug?
Most of the internet searches I conduct produce results that mention ongoing clinical trials.
Hi,
now news yet?
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