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        Enteral Carbidopa/Levodopa (Duodopa) Alleviates Motor Symptoms, "Off" Times in Parkinson's Disease: Presented at MDS

        By Paula Moyer

        ROME, ITALY -- June 21, 2004 -- An enterally infused gel formulation of carbidopa/levodopa (Duodopa) is more effective as monotherapy than a cocktail of oral therapies for patients with Parkinson's disease who have motor fluctuations and dyskinesias, according to findings presented here June 15th at the 8th International Congress of the Movement Disorder Society.

        "The enteral infusion offers an important alternative for patients with advanced Parkinson's disease," said Dag Nyholm, MD, consultant neurologist, Uppsala University Hospital, Uppsala, Sweden. He noted that patients in the study reported a higher quality of life and greater satisfaction with their motor functioning when treated with the enteral formulation.

        The researchers wanted to compare enteral levodopa monotherapy, infused over a 16-hour period during the day, to individually optimized conventional combination therapies that are often used to treat patients with advanced Parkinson's disease. They conducted a randomized crossover study in 24 patients with Parkinson's disease and motor fluctuations treated with individual conventional treatment or the investigative formulation for 3 weeks each.

        They were interested in an enteral formulation because the conventional oral therapies are often inadequate to control the motor fluctuations of advanced Parkinson's disease. Since the enteral formulation offered a nearly constant plasma levodopa concentration, the investigators wanted to see if it therefore provided continuous dopaminergic stimulation and therefore better control of motor fluctuations.

        Video recordings of each patient were made every 30 minutes for 8 hours on 2 days in each treatment arm. A blinded observer assessed each video for motor function and gave a score on a Treatment Response Scale (-3 for severe parkinsonism, 0 for normal function, and +3 for severe dyskinesia). Patients used an electronic diary to record real-time self-assessment of motor function and quality of life.

        Median time in a near normal motor state, scores of -1 to +1, increased from 81% to 100% with infusion therapy (P <.01). Patients also had a significant decrease in median score on the Unified Parkinson's Disease Rating Scale, from 53 (range 14 to 80) on conventional therapy to 35 with enteral therapy (range 19 to 63) (P <.05).

        The investigators obtained quality-of-life data from the Physicians' Data Query-39, the Measure of Health Related Quality of Life 15D questionnaire (15D), and the patients' electronic diaries. These instruments showed higher quality-of-life assessments when patients were on enteral therapy, Dr. Nyholm said.

        The study was funded by NeoPharma, the manufacturers of Duodopa.


        [Presentation title: Enteral Levodopa Infusion as Monotherapy is Superior to Conventional Oral Treatment of Advanced Parkinson's Disease. Abstract P500]



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