New Trial - we need participants!
 

Duodopa is a treatment that hsA been used in Europe for some time. Now it's finally here in the US! It sounds like one of the most promising treatments for those radical off/on times (including dyskinesia).

I cannot join this trial because I had experimental brain surgery, so help out if you fit the criteria (go to the link for inclusion/exclusion criteria):

From PDtrials - Parkinson's Disease Clinical Trials
http://www.pdtrials.org/en/browse/all/view/250

Safety and Efficacy Study of Levodopa–Carbidopa Intestinal Gel in Levodopa-Responsive Participants with Advanced Parkinson's and Severe Motor Fluctuations

Official Study Title: Open-Label, Open-label (NOTE: No sham surgery!

A trial design that allows the researcher and the study participant to know what treatment the participant is receiving. This is the opposite of double-blind study. 6-12 Months Safety and Efficacy Efficacy
The extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions.

Study of Levodopa– Levodopa
A compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. Carbidopa Carbidopa
Drug given in combination with levodopa to ensure that more of the latter reaches the brain and changes into dopamine, rather than being broken down in the bloodstream. This allows for lower doses of levodopa to be used, reducing the risk of nausea, vomiting, and other side effects. Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease Parkinson's Disease

A chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. and Severe Motor-Fluctuations
Sponsor: Solvay Pharmaceuticals B.V.
Clinicaltrials.gov ID: NCT00335153
Study ID: S187.3.004


Summary

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel over six to 12 months in people with advanced Parkinson’s disease (PD) and severe motor-fluctuations who have not had optimal response to oral levodopa-carbidopa treatment. Additional supportive evidence for efficacy will be assessed in the treatment of severe motor fluctuations, dyskinesia Dyskinesia
Twisting, turning or other abnormal involuntary movement usually involving the arms, legs, trunk, and head. It is most commonly associated with long-term use of levodopa. and mobility.

Levodopa-carbidopa intestinal gel is delivered to the upper intestine through a permanent extension tube inserted via percutaneous endoscopic gastrostomy (PEG-J, or a surgical procedure for placing the tube without having to perform an abdominal operation), for long-term treatment.

The delivery of levodopa-carbidopa intestinal gel directly to the upper intestine is anticipated to result in: continuous delivery of levodopa-carbidopa, avoidance of pulsating gastric emptying, and decreased motor fluctuations and dyskinesia.

Wow! Sign me up!
 

[QUOTE=pegleg;469130]Duodopa is a treatment that hsA been used in Europe for some time. Now it's finally here in the US! It sounds like one of the most promising treatments for those radical off/on times (including dyskinesia).

I cannot join this trial because I had experimental brain surgery, so help out if you fit the criteria (go to the link for inclusion/exclusion criteria):

From PDtrials - Parkinson's Disease Clinical Trials
http://www.pdtrials.org/en/browse/all/view/250

This therapy has interested me for a long time. I have severe on/off fluctuations with dyskinesia. My greatest challenge is eating as I'm extremely sensitive to eating anything. I have a problem getting enough calories and nutrition unless I spend 2-3 hours off after every meal or snack. If I push my sinemet at all to try to get a little more on time I risk dyskinesia.

I read through the inclusion/exclusion criteria and I think I'm an ideal candidate for this trial. How to proceed? Is it best to pursue this through my neurologist?

It's always a good idea to discuss any change in your treatment with your doctor. There are actually two trials for Duodopa - the one for advanced patients and one to test the gel against oral medications.
see here
http://www.pdtrials.org/en/browse/all/view/249

Check out more details on the one for advanced patients here:
http://www.clinicaltrials.gov/ct2/show/NCT00335153

they give you a contact - your doctor's office may be able to help you.

Good luck and keep us posted!

Peggy

me too shcg - hope i wrote it in the right order....your user ID doesn't, no it cannot..slide off my tongue...had to memorize it visually lol.

i was waiting for this one for quite awhile. then i saw that you have a daily, external component to connect or to refill [?].and take care of ...is that correct? It must always be worn?

So I started looking at ceregene....but sounds like they are still engineering away. Placebo and sham surgery not viewed the same by different stakeholders.

i should give this one another look. DBS is still not something I feel comfortable about... duodopa sounds like it could be difficult but maybe a needed change through balancing some things together, if not everything . so many systems. what happens when they come unwound? which system is holding up the other? it should be an option.

I will look at it again and thanks peg......insight says it all.

paula

syntax
 

I am of course not eligible for this trial as I live in the UK. I was however very interested (in the context of a point raised recently in another discussion) in the following:

A chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. and Severe Motor-Fluctuations

The grammar/syntax here seems to me to be faulty - I cut and pasted it so it was accurately copied - so I followed up Peg's links to the trials and was not reassured. As far as I know severe motor fluctuations are not symptoms of PD but of long term levodopa usage. While the more detailed trial text does define this well I do have concerns that dyskinesias are now sometimes represented as a 'symptom' of PD. This may be splitting hairs for people who are NOT pwps, but........

Sorry I do not mean to hijack your thread Peg, especially as this does look to be a promising treatment for many people especially those whose levodopa options are getting thin.........

Lindy