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Old 02-21-2009, 07:00 AM
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pegleg pegleg is offline
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Join Date: Sep 2006
Location: Tennessee
Posts: 1,213
15 yr Member
pegleg pegleg is offline
Senior Member
pegleg's Avatar
 
Join Date: Sep 2006
Location: Tennessee
Posts: 1,213
15 yr Member
Default 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.
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