Imark, does budipine have a market name like nortriptyline is Pamelor, etc.
do you know if it is approved in the US?

Laura,
"Thou shalt not sell a treatment in the USA previously approved in Europe without conducting double blinded trials with a placebo !"

Does that include sham surgery?

"it does"
The FDA has spoken. Reasoning is not required. Best example i can think of is duodopa . I"m sure there are enough recipients in Euope 10 [well we keep saying 10 but it's probably been 15 now] years into the use of this treatment in Europe . Perry Cohen consulted for them at one point and helped to arrange some of the communications.

It's been taking several years of unneutral time. I used to think that it would be the one for me and i've read about great changes in the partcipants. I've never seen one up close but refilling it seems daunting for two not quite functioning hands. I asked the company at a PAN conference and then again unfortunately at the following year's conference.. Both times they made cracks about the FDA; one rep said ,"I don't understand them."

This trial protocol has killed several promising treatments at phase II and what are they going to do if duodopa fails phase 2? Ignore the potential when it's already on the market outside the USA? Maybe they have finished phase 2.

I wonder how many sub types are being cateforized from the intake information..I'm going to call somebody and find out or please post if you know anythng.

T0 the participants in the duodopa trial -- please update us as specifically as you can. That request is now global. maybe we could collect some data and compare it to what the doctors are thinking. This trial is unique because it's been in use already. There is a group exchanging information in the clinical trials subforum...putting out an all call for anyone in the trials or who takes it in Europe . Altho there will be questions for the participants, please tell us what you can.[are permitted].

you can go right to the heard of the matter and tell us if:

it works

it is better than oral meds were

was it worth the time, energy and risk?

are you getting it after the trials finished as compassionate use. I can't see changing and adjusting to something successfully, getting your life back, and then taking it away.GDNF all over again. A contributing factor was the pump/catheter that functioned so well in the UK was not FDA approved. Theyh used one from medtronics.

you can sleep on it

other potential things participants could pass on if permitted:
let us know if:

pump is a nuisance or painful? infections easily avoided?

is it easy to refill for pwp with our degree of fine motor difficulty?

has it changed your life ? how so?

does it give you nausea?

will the placebo participants be allowed in phase 3?

This one should be a no brainer to figure out if you've gotten the real thing. IS that true? Don't they think a person could just skip his meds and see how bad it gets?

ok should i move this to its own thread?

i was explaining to laura just how poorly the treatment pipelines perform and the fact that not one patient was asked to testify. patients could perforn better in that capacity if they are also trained to be clinical triial advocates.

The fierce urgency of now quote that Bryn used is also the first thing you read in our book. That quote is from Martin Luther King and it fits like a glove. Let's start stressing that we want patients at any pd policy planning, clinical trial planning , or process reviews tables as well as on IRBS. We want it now! Our goal should be to cancel the world pd congress in Montreal in 3 years due to lack of Parkinson's disease.


and imark thanks for the tip about budipine. is it available in Canada?

Here's a link to one happy customer about duodopa if interested.
http://neurotalk.psychcentral.com/sh...945#post701945