Double‐blind study of pardoprunox,a new partial dopamine agonist,in early Parkinson's disease |
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| Authors: | Juliana Bronzova MD Cristina Sampaio MD PhD Robert A Hauser MD Anthony E Lang MD Olivier Rascol MD Ad Theeuwes MSc Serge V van de Witte PhD Guus van Scharrenburg PhD |
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| Institution: | 1. Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands;2. Department of Pharmacology, Faculdade de Medicina de Lisboa, Lisbon, Portugal;3. Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA;4. Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada;5. Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825, Toulouse, France;6. Members of the “Bruegel Study Group” are listed as an Appendix. |
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| Abstract: | This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9–45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti‐Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)‐Motor score was improved in pardoprunox‐treated patients (overall mean dose 23.8 mg/d; ?7.3 points), as compared with placebo (?3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥30% reduction in UPDRS‐Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS‐activities of daily living (ADL) and ‐ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox‐treated patients (vs. 3/70, 4.3%, placebo‐treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof‐of‐concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD. © 2010 Movement Disorder Society |
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| Keywords: | Parkinson's disease partial dopamine agonist monotherapy pardoprunox randomized controlled clinical trial |
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