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01-14-2007, 06:42 PM | #1 | ||
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In Remembrance
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http://www.clinicaltrials.gov/ct/show/NCT00357994?
http://duodopa.com This one I think I will try to get into - sites in link. Not recruiting yet. Purpose The primary objective of this study will be to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.The study duration is 4 months. Condition InterventionPhaseParkinson's Disease Severe Motor Fluctuations Dyskinesias Drug: Levodopa-carbidopa intestinal gel Phase III MedlinePlus related topics: Neurologic Diseases; Parkinson's Disease Genetics Home Reference related topics: Parkinson disease Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study Official Title: A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa/Carbidopa Suspension for Upper-Intestinal Infusion in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations Further study details as provided by Solvay Pharmaceuticals: Primary Outcomes: Efficacy will be assessed using the subject diary for “on”/”off” time and “on” time without troublesome dyskinesia, UPDRS, CGI-I, CGI-S Secondary Outcomes: UPDRS, CGI-I, CGI-S Expected Total Enrollment: 54 Study start: January 2007 Eligibility Ages Eligible for Study: 30 Years and above, Genders Eligible for Study: Both Criteria Inclusion Criteria:
Please refer to this study by ClinicalTrials.gov identifier NCT00357994 Staci Rokette staci.rokette@solvay.com Alabama Site 8, Birmingham, Alabama, United States Florida Site 1, Gainesville, Florida, United States Site 5, Tampa, Florida, United States Site 6, Jacksonville, Florida, United States Georgia Site 7, Atlanta, Georgia, United States Kansas Site 4, Kansas City, Kansas, United States Massachusetts Site 10, Boston, Massachusetts, United States New York Site 2, Albany, New York, United States Site 9, New York, New York, United States Rhode Island Site 3, Warwick, Rhode Island, United States Germany Site 11, Marburg, Germany Site 12, Leipzig, Germany Site 13, Bochum, Germany Site 14, Hannover, Germany Site 15, Bremerhaven, Germany Study chairs or principal investigators Global Clinical Director Solvay, Study Director, Solvay Pharmaceuticals More Information Study ID Numbers: S187.3.001; 2006-000577-29 Last Updated: November 7, 2006 Record first received: July 27, 2006 ClinicalTrials.gov Identifier: NCT00357994 Health Authority: United
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paula "Time is not neutral for those who have pd or for those who will get it." |
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01-15-2007, 05:25 AM | #2 | |||
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I saw a presentation about this at the 2003 (I think) PAN forum. The test subject had all his dyskinesia eliminated and his off-time significantly reduced. I think pill form is the worst way we can take our levodopa. The continuous, or hourly dosing with liquid sinemet seems to cause MUCH less in the way of side effects, dyskinesia and "off type"
such as bradykinesia and dystonia. This is an understudied therapy, probably because it uses "off the self" technology. Charlie |
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01-16-2007, 07:51 AM | #3 | ||
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my neuro, (not an excitable man), was really excited about the results of the Duodopa trials to that date.
Aftermathman. |
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