Posted by Elroy on June 3, 2005, at 21:16:24
In reply to Anxiety, Ocinaplon and clinical trials, posted by pseudonym on March 14, 2005, at 22:41:34
Is this the study you refered to?
QUOTE:
28-Day, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Safety and Efficacy Study of Ocinaplon in Patients with Generalized Anxiety DisorderPrincipal Investigators:
Mahlon S. Hale, MDDescription of Study:
Do You Suffer from Anxiety?
The Behavioral Health Research Center at New Britain General Hospital is currently studying and investigational treatment for anxiety.
People with anxiety often experience: uncontrollable worry, irritability, difficulty concentrating, restlessness, problems with sleep, and are easily fatigued.
Study participants will receive a comprehensive evaluation and investigational drug at no cost. Reimbursement for time and travel expenses is also available.Eligibility Criteria:
Men and women, 18-65 years old with a diagnosis of Generalized Anxiety DisorderLocation:
New Britain General Hospital
New Britain, CTContact:
Alison Ovill, Project Manager
(860) 224-5597
aoville@nbgh.orgwww.nbgh.org/behavioral.html
END QUOTEI have tried to contact them via e-mail in regards to getting into this study but have received no reply to this daate (has been for about a week now).
Elroy
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> 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.
>
> 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.
>
> 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.
>
> 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?
>
> 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.
poster:Elroy
thread:471132
URL: http://www.dr-bob.org/babble/20050601/msgs/507474.html