The CEO of Xicepta, Dr. Soledad Manaay, answered as follows when I asked if it was ok to recruit more people for the study:

*edit*
As part of the study you get 60 days of Agitan X for free.

If you are interested contact her at *edit*

I applaud those willing to give it a shot. We will all appreciate your feedback and updates. Please keep in mind when you self analyze, mucuna along with some placebo effect can go a long way to making you feel a little better.

With regard to their starting "clinical" trials soon, I highly doubt it. They may conduct their own anecdotal study, but there is no evidence at all that they are going for FDA approval to begin a phase 1, 2 or 3 trial. I've searched everywhere and called all of my contacts. No one knows them. For those in contact with the company, why not ask them for some of the details like where the trials will be conducted; what is the study design, how long is it, who is the independent monitor, when are they meeting with the FDA for design approval, when will we see it on clinicalgov.com?

I hate to be negative because I generally have hope and positive feelings. However, past experiences with these type of untested "hype" drugs/companies leaves one highly sceptical......

Dr Manaay appears to be involved in entities other than Xicepta.

For example, she is the CEO of a company called Biologic Cosmetics, Inc. (http://issuu.com/solmanaay).

This company (http://biologiclife.com/) provides (for a fee) "Caviar and Stem Cell-Based Revolutionary Skin Care" (http://biologiclife.com/about/).

Other members of the NeuroTalk community may wish to draw their own conclusions from this.

AGAIN, one has no "proof" of what's in this supplement. if this company's goal was to get the attention of a lot of pd'ers they might have accomplished it.

a poorly designed clinical trial isn't worth doing and like TUPELO3 stated, the placebo affect is incredibly strong in pd'ers willing to risk their health to try something new, look at all the gene therapy trials that had great results in phase 1 where everyone knew they were getting the treatment and had no statistically significant benefit in phase 2 when the placebo affect was accounted for.

the only proven treatment that reversed pd symptoms has been fetal cell transplants. and gene therapy has required surgery cuz the genetic material has to be delivered to the right part of the brain, not the whole brain. and may not pass the blood brain barrier.

if dopamine producing brain cells could be stimulated to change just by eating and drinking something think about the chaos in your brain. you'd eat a steak and your head would burst! just being slightly silly. but that's why we have a BBB, to protect the brain and limit passage of most molecules and highly regulated systems for controlling the production/destruction of neurotransmitters.

wait.....Information molecules from food called micro RNA instructs our genes says Dr. Bruce Lipton and new discovery regarding the science of epigenetics (who also validates placebo response) ? https://www.youtube.com/watch?v=TtwTEHW8_8k

i'm not commenting on whether an ingredient may or may not be effective, i'm saying there is no way to know what they are actually putting in this capsule.

http://www.xicepta.com/x-study.html

Anyone want to wade through this?

http://www.xicepta.com/patent.html

I looked at this yesterday. Honestly, it seems to me to just be a way to sound legitimate by using fancy scientific lingo. To me it means nothing because, as ST previously said, we have no way of proving or disproving any of it without bringing a sample to a lab and having it tested. I'm not trying to imply anything, but for all we know its just sugar. Or, maybe the amount of mucuna is greater than implied (and why would they need that in the formula anyway). They may even have some levodopa in there to enhance an effect. The problem is, we just don't know. Keep in mind, xicepta is just licensing the product. I don't think they had anything to do with it's origination.

I completely understand and appreciate the spirit of your post but I would like to remind everyone that there are numerous studies that do show reversal of symptoms with various forms of B vitamins. It's no placebo effect when your tremors and unsteady pace are vastly reduced. These studies are referred to in other postings here BTW. To each their own but it's pretty hard to affect physical PD symptoms via placebo effect.