Parkinson's Disease Clinical Trials For posting and discussion of clinical trials related to Parkinson's Disease, and for the Parkinson Pipeline Project. All are welcome.


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Old 01-30-2011, 08:12 PM #1
illbethere illbethere is offline
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Join Date: Jan 2011
Posts: 23
10 yr Member
illbethere illbethere is offline
Junior Member
 
Join Date: Jan 2011
Posts: 23
10 yr Member
Default IPX066 Open Label Extension Study

This is a note to those who are enrolled in Impax Lab's IPX066 Open Label Extension Study or anyone else who is concerned about the ethics of PD trials.

IPX066, is an extended release formulation of Carbidopa/Levodopa. I've been taking it for over a year and it has resulted in a significant improvement in the quality of my life.

From what I've heard, it has worked well with others and it's just a matter of time before it is approved for sale.

Unfortunately, I just learned that Impax Labs has not agreed to continue to provide IPX066 until it is available on the open market. This will force me and other enrollees to go back to using an inferior drug like Sinemet, which has a number of nasty side effects, including dyskinesia.

If you agree with me that the sponsor should continue to provide the study drug until FDA approval to those trial participants who request it, then it might be helpful if you wrote a note to the sponsor requesting that they change their policy.

You can write to the study director, Dr. Jeff Mulchahey. He can be reached at *edit* contact poster for details .

The details of this trial can be found at clinical trials.
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ethics in trials, impax labs, ipx066, open lable extension


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