[paula_w]

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:

• <LI style="MARGIN-TOP: 2px">idiopathic parkinson’s disease(PD)according to UKPDS Brain Bank Criteria
• levodopa-responsive with severe motor fluctuations
• recognizable off and on state (motor fluctuations) confirmed by diary

Exclusion Criteria:

• <LI style="MARGIN-TOP: 2px">Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
• undergone surgery for the treatment of PD
• contraindications to levodopa (such as hyperthyroidism, etc.)

Location and Contact Information
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

[chasmo]

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

[aftermathman]

my neuro, (not an excitable man), was really excited about the results of the Duodopa trials to that date.

Aftermathman.