Posted by KaraS on March 15, 2005, at 3:39:02
In reply to Anxiety, Ocinaplon and clinical trials, posted by pseudonym on March 14, 2005, at 22:41:34
> Well, I attempted to enter the ocinaplon phase III GAD trial recently. To remind some of you, ocinaplon is an anxiolytic (with a new mechanism of action, no copycat here) undergoing phase III clinical trials, and its basically operates on anxiety exclusively without sedating you, causing forgetfulness, potentiating alcohol, and causing physical dependence. In other words, Its precisely what I've been hoping for, since I'd like to have a life not dominated by unnatural fear.
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> Anyway, my blood test for entry into the trial comes back with higher than allowed liver enzyme levels. Not much higher than allowed, but higher, so I'm excluded from the study. I think to myself, "Good luck getting the volunteers you need for this study", and I certainly hope they do.
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> As it turns it out, they must be having touble getting not just volunteers, but non-excluded volunteers, because they've made a request to the FDA to allow them to test people with normal liver function, just to get the safety data. Of course, phase II was aout the safety data, but they had a single patient have a liver problem (apprently pre-existing) and that's going to end up causing 2 years of delay. Apparently its not easy finding the "perfect" GAD patient.
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> So that pushes the enrollment, not the completition, but the enrollment of the phase III ocinaplon study out to mid 2006. Remember when they were ready go to phase III with Ocinaplon in October 2003?
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> This compound seems like a great idea, in that it works only on the anxiolytic GABA-A receptor subunits. The cat is out of the bag on GABA-A subunits, and better anxiety relief will come for us GAD/Social Anxiety sufferers. Let's just hope that ocinaplon makes it.
Hi pseudonym,I remember you (&/or others) mentioning ocinaplon before. How discouraging that we have to wait so long to find out if it's even going to make it through the process. It does sound too good to be true though. If it lived up to its hype it would quickly dominate the market. Where is the study being conducted? Are you at all interested in Lyrica which is supposed to be on the market in the U.S. soon?
Do you mind if I ask what you currently take for anxiety? I know that you've been taking selegiline + DLPA for depression. One of the reasons I'm not taking it is that I have so much anxiety already and I'm afraid to add to it. How have you dealt with this problem? I am currently taking 25 mg. of doxepin which is helping immensely but I'm afraid of combining it with the selegiline. Also, I may have to go off of the doxepin because of its cardiotoxicity so I may need to find another alternative. I'm trying to figure out how to deal with the GAD without regular benzo use - if that's possible at this point. If only ocinaplon were available!
Kara
poster:KaraS
thread:471132
URL: http://www.dr-bob.org/babble/20050312/msgs/471194.html