A phase III trial is coming to the U.S. in a few months. I called on this one as there are two locations in Florida, and I am very interested. My thyroid may disqualify me but I'm still encouraged that it is a Phase III trial.
From the PDPipeline database: Duodopa
Treatment Information
Treatment Name Duodopa
Symptoms Addressed Balance Bradykinesia Cognitive Problems
Treats general (not specified) PD symptoms Tremor
Trial Type
Treatment of Motor Symptoms
Trial Type Notes
As of January 2007, U.S. phase III clinical trial is planned, but recruitment has not started. (clinicaltrials.gov) A call was made in Jan. 2007 to the recruitment contact number. Advised to call back "in a few months."
Treatment Class Levodopa
Treatment Description "Treatment based on continuous dopaminergic stimulation by means of a formulation of levodopa and carbidopa, dispersed as a viscous gel. Using a patient-operated portable pump, the drug is continuously delivered via a tube directly into the upper small intestine, where it is rapidly absorbed. This delivery system ensures a more even supply and uptake compared with the conventional combination of tablet treatment." (Solvay web site)
Intended for people in late stages of Parkinson's.
Foreign Market Info DUODOPA is authorized for "treating advanced Parkinson’s disease in 28 European countries - Sweden, Austria, Germany, Denmark, Spain, Finland, France, The Netherlands, Norway, Portugal, Belgium, Greece, Ireland, Italy, United Kingdom, Cyprus, Czech Republic, Estonia, Hungary, Iceland, Liechtenstein, Lithuania, Luxembourg, Latvia, Malta, Poland, Slovenia, and Slovakia." Received orphan drug status (press release 12/05)
Treatment Status In Clinical Trials (Outside US)
Recruiting Status (For current trial recruitment information see
PDTrials.org )Trial is not recruiting Patients
Comments NeoPharma was acquired by Solvay Pharmaceuticals in Jan. 2005.
Phase IV trials are underway in Sweden and Norway. They are recruiting patients in Sweden for Phase IV study of "Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-Benefit."
Trial information available at:
http://www.clinicaltrials.gov/ct/show/NCT00272688?order=2 and
in Norway for phase IV trial "DAPHNE (Duodopa in Advanced Parkinson’s: Health Outcomes & Net Economic Impact)."
Trial information available at:
http://www.clinicaltrials.gov/ct/sho...der=1Sponsor(s)
Sponsor (click for details) URLPrimary Sponsor
Solvay Pharmaceuticals, Inc. Subsidiary of Solvay SAhttp://www.solvay.com/
There is more info about the clinical trials thus far in the pipeline database.
Paula