Psycho-Babble Medication Thread 471132

Shown: posts 1 to 9 of 9. This is the beginning of the thread.

 

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.

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.

 

Re: Anxiety, Ocinaplon and clinical trials » pseudonym

Posted by Phillipa on March 15, 2005, at 0:00:36

In reply to Anxiety, Ocinaplon and clinical trials, posted by pseudonym on March 14, 2005, at 22:41:34

I'll second that! Fondly, Phillipa

 

Re: Anxiety, Ocinaplon and clinical trials » pseudonym

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.
>
> 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.


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

 

Re: Anxiety, Ocinaplon and clinical trials

Posted by jrbecker on March 15, 2005, at 9:33:23

In reply to Re: Anxiety, Ocinaplon and clinical trials » pseudonym, posted by KaraS on March 15, 2005, at 3:39:02

it's extremely unfortunately, but analysts are predicting a big slowdown on approval timelines from the FDA. Given all the media attention currently surrounding the agency, there is enormous pressure to put more scrutiny on safety protocols.

I think DOV is doing the right thing by being proactive with further liver testing. This will most likely expedite the review process once submitted. So perhaps this will actually save some time in the end. But once again, I think we'll see the typical drug review timeframe of 12-16 months no longer be the norm -- at least until less criticism falls on the agency.

 

Re: Anxiety, Ocinaplon and clinical trials

Posted by Steve3211 on March 15, 2005, at 15:30:06

In reply to Re: Anxiety, Ocinaplon and clinical trials, posted by jrbecker on March 15, 2005, at 9:33:23

So when possibly could we see a possible approval or release of phase III into pending approval.
Best Steve

 

Re: Anxiety, Ocinaplon and clinical trials

Posted by pseudonym on March 16, 2005, at 18:38:48

In reply to Re: Anxiety, Ocinaplon and clinical trials » pseudonym, posted by KaraS on March 15, 2005, at 3:39:02

The ocinaplon study is being conducted in multiple centers ( I believe 45 centers averaging around 7-8 patients). As far as Lyrica is concerned, that may work. I think that it may take 6 months to figure out if Lyrica works in the clinic for social anxiety and/or GAD diagnosed individuals.

My current regimen is pretty spare. Exercise in the morning, then 1 mg of selegiline. The PEA sparing effects of exercise and selegiline are noticable for about 4 hours. I also take klonopin, the brand variety, at .75 mg per day.

 

Re: Anxiety, Ocinaplon and clinical trials » Steve3211

Posted by pseudonym on March 16, 2005, at 18:46:34

In reply to Re: Anxiety, Ocinaplon and clinical trials, posted by Steve3211 on March 15, 2005, at 15:30:06

> So when possibly could we see a possible approval or release of phase III into pending approval.
> Best Steve

Well, I need to educate myself more on the FDA's procedures, because at one time the pacing item for ocinaplon regarding phase III was the two year carcinogenicity study. Perhaps others know better. If they have all the enrollees by July 2006, let's say, and the study takes 6 weeks, I'm not sure how long at that point, assuming safety is established, the collation, submission, and turnaround might be.

 

Re: Anxiety, Ocinaplon and clinical trials » pseudonym

Posted by KaraS on March 16, 2005, at 21:52:13

In reply to Re: Anxiety, Ocinaplon and clinical trials, posted by pseudonym on March 16, 2005, at 18:38:48

> The ocinaplon study is being conducted in multiple centers ( I believe 45 centers averaging around 7-8 patients). As far as Lyrica is concerned, that may work. I think that it may take 6 months to figure out if Lyrica works in the clinic for social anxiety and/or GAD diagnosed individuals.
>
> My current regimen is pretty spare. Exercise in the morning, then 1 mg of selegiline. The PEA sparing effects of exercise and selegiline are noticable for about 4 hours. I also take klonopin, the brand variety, at .75 mg per day.


That is pretty spare! Only 1 mg. of selegiline and no DLPA. Wow! The exercise must substitute for the DLPA and you're just hoping to replace the klonopin with ocinaplon. Thanks for your response and I wish you continued success on your program. I'm still crossing my fingers for all of us on ocinaplon.

Take care,
Kara


 

Re: Anxiety, Ocinaplon and clinical trials » pseudonym

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 Disorder

Principal Investigators:
Mahlon S. Hale, MD

Description 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 Disorder

Location:
New Britain General Hospital
New Britain, CT

Contact:
Alison Ovill, Project Manager
(860) 224-5597
aoville@nbgh.org

www.nbgh.org/behavioral.html
END QUOTE

I 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
X
X
X
X


> 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.


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