Posted by Elroy on June 3, 2005, at 21:10:35
In reply to Latest on Ocinaplon, posted by Michael Bell on May 14, 2005, at 11:33:05
The test that you were refering to, was it this one:
28-Day, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Safety and Efficacy Study of Ocinaplon in Patients with Generalized Anxiety Disorder
Principal 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
Elroy
X
X
X
X
> I was wondering what's been happening with Ocinaplon since the phase III trials started in November '04. Here's an article I found dated March 30, 2005. I believe the studies are supposed to finish by late 2006, but who knows?
>
>
> A. Lippa *, P. Czobor *, J. Stark *, B. Beer *, E. Kostakis , M. Gravielle , S. Bandyopadhyay , S. J. Russek , T. T. Gibbs , D. H. Farb , and P. Skolnick *
> *DOV Pharmaceutical, Inc., 433 Hackensack Avenue, Hackensack, NJ 07601; and Department of Pharmacology, Boston University School of Medicine, 80 East Concord Street, Boston, MA 02118
>
>
>
> Communicated by John W. Daly, National Institutes of Health, Bethesda, MD, March 30, 2005 (received for review November 8, 2004)
>
> Benzodiazepines remain widely used for the treatment of anxiety disorders despite prominent, often limiting side effects including sedation, muscle relaxation, and ataxia. A compound producing a robust anxiolytic action comparable to benzodiazepines, but lacking these limiting side effects at therapeutic doses (an anxioselective agent), would represent an important advance in the treatment of generalized anxiety disorder, and perhaps other anxiety disorders. Here we report that the pyrazolo[1,5-a]-pyrimidine, ocinaplon, exhibits an anxioselective profile in both preclinical procedures and in patients with generalized anxiety disorder, the most common of the anxiety disorders. In rats, ocinaplon produces significant muscle relaxation, ataxia, and sedation only at doses >25-fold higher than the minimum effective dose (3.1 mg/kg) in the Vogel "conflict" test. This anticonflict effect is blocked by flumazenil (Ro 15-1788), indicating that like benzodiazepines, ocinaplon produces an anxiolytic action through allosteric modulation of GABAA receptors. Nonetheless, in eight recombinant GABAA receptor isoforms expressed in Xenopus oocytes, the potency and efficacy of ocinaplon to potentiate GABA responses varied with subunit composition not only in an absolute sense, but also relative to the prototypical benzodiazepine, diazepam. In a double blind, placebo controlled clinical trial, a 2-week regimen of ocinaplon (total daily dose of 180-240 mg) produced statistically significant reductions in the Hamilton rating scale for anxiety scores. In this study, the incidence of benzodiazepine-like side effects (e.g., sedation, dizziness) in ocinaplon-treated patients did not differ from placebo. These findings indicate that ocinaplon represents a unique approach both for the treatment and understanding of anxiety disorders.
>
>
poster:Elroy
thread:497685
URL: http://www.dr-bob.org/babble/20050601/msgs/507469.html