As we watch another treatment disappear, instead of continuing on to its final conclusion of being pronounced safe and effective or not, the prematurity and length of time, as other [almost all?] treatments are experimented with is not held up waiting for its efficacy, but rather due to funding and regulations.

DID IT WORK????

i hear there are just 34 of you participants. it is imperative that we know how this is being handled and that you are medically safe. otherwise the pipeline project and others haven't been heard and will have to be louder over this particular treatment.

Is a big company going to take over? with a few specifics we could help possibly.

we fought hard for the gdnf participants and we want to guarantee your follow up. are there placebos who can't ever get it now? that bothers me more than anything after safety. this happens too often , if it's a good treatment the NIH needs to get involved. they have alll the money and it's time for them to use it for treatments.

others please post on all places where you write about this search for GAD participatants. As far as I know they wanted to move on to phase III.

shoot i lost the first one. i hear there are just 34 participants . have they been unblinded? will the placebos not get anything now? that makes me so angry - people get their heads drilled and nothing for it. this is inexcusable. i hope someone in the know will inform us about the details, even the researchers for neurologix. it's important that patients get involved here and it's time for the govt. to bail out these companies who have success and are ready for phase III. i'm starting to think there is no phaseIII in parkinson trials. is a hybrid car worth more than peoples lives - millions having surgery and suffering - who could use the funding in a more deserving way. we have lost the priority of human life and replaced it with money and world control. watch Damascus.

please update if u know anything.
thank you

Dear Paula_w. The Neurologix story is tragic, as clearly the intervention had efficacy, with almost everyone in the study gaining some benefit. Most importantly, there were no significant adverse events, an achievement in itself. A total of 45 people were enrolled in the study and randomized one to one. 22 received the AAV-GAD active treatment, 23 received sham. A few patients randomized to GAD didnt receive the treatment as indicated, either because of missed target (the blinded design prevented revision surgery that is commonly carried out with DBS to ensure correct targeting). Moreover as the device used to deliver the GAD gene (AAV-GAD or NLX-P101) is not a commercial device, but still undergoing development, and so there were a few problems with infusion, pump failures etc. In the end 16 individuals got the treatment as intended. the other subjects either got partial treatment, or missed target or the device slipped out of the target prior to infusion. Of the patients randomize to the burr hole only (sham surgery), 14 of that group has now received the GAD treatment, with no significant problems reported. My understanding is that only 2 of the remaining 9 sham subjects were eligible candidates to receive GAD, and it is tragic that with the demise of NRGX, that the study is terminated. The hope is that the original developers of this technology can move forward with a new trial, fully optimized in every way. The Neurologix Phase 2 was the first of any biological therapy to reach its primary endpoint, with 10 of the subjects at one year having improved by 9 points or more on their UPDRS(motor) OFF scores. Moreover, those who didnt get such a good response on UPDRS still improved with increased ON time of at least 2 hours during the waking day. Hence, although the approach is no cure, it is a significant advance, and so it would be great if the inventors can move it along..

we've been tracking clinical trials for over a decade and it's refreshing to get a detailed reply about a cancellation. It also lets us know that the sham surgeries were treated, something that is so very important to patients. You seem to have left room for it coming back, altho i am not implying that this is fact.

with appreciation,
paula

I was a Neurologix Phase 2 participant. I got the sham surgery in 2009 and I was scheduled to get the real procedure in Nov 2011. The procedure was cancelled that same month due to Neurologix financial issues. The researchers I was working with did not know of anyone willing to pick up where Neurologix left off when I talked with them in Jan 2012

and to add insult to injury, they don't give you an explanation. i will check around to see if there is any info to be found, but people like you are why we advocate against sham surgery.

wishing you the best.

Mirapex Lawyer: Jones Ward PLC Files Lawsuits Alleging RLS & Parkinson's Drug Causes Compulsive Gambling & Other Complusive Behavior

October 4, 2010, by JONES WARD PLC



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Jones Ward PLC's lawyers have filed numerous Mirapex lawsuits, perhaps more than any other firm in the country. The federal lawsuits allege that the popular drug Mirapex, prescribed primarily to treat the symptoms of Restless Legs Syndrome (RLS) and Parkinson's Disease, can cause compulsive gambling, hypersexuality and other compulsive disorders. Indeed, we represent clients who have lost hundreds of thousands of dollars due to uncontrolled gambling.

A series of scientific studies published in prominent medical journals, such as Neurology, and conducted by highly-regarded medical research institutions, such as the Mayo Clinic, show that dopamine agonists -- the class of drugs to which Mirapex belongs -- can cause compulsive gambling and other compulsive behavior in people who have never had a problem with gambling or compulsive behavior.

In most cases studied, the desire to gamble or other compulsion ends immediately upon discontinuing Mirapex. For example, according to a 2008 study of more than 3,000 Parkinson's patients, those on dopamine agonists like Mirapex are nearly three times more likely to have at least one impulse-control disorder, including gambling addiction, compared to those receiving other treatments. Mirapex contains a chemical that attaches to the dopamine receptors in the brain linked to pleasure and reward-seeking behavior.

Anyone wishing to discuss a potential Mirapex lawsuit with an experienced Mirapex lawyer is encouraged to call Jones Ward PLC at 1-866-587-0002 or email larry@jonesward.com.

Posted by Louisville, Kentucky lawyer Larry Jones. Larry can be reached at larry@jonesward.com or by using his toll-free number 1-888-KYLAW22.