Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study |
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| Authors: | Anthony H.V. Schapira MD DSc FRCP FMedSci Stefan Albrecht MD Paolo Barone MD Cynthia L. Comella MD Michael P. McDermott PhD Yoshikuni Mizuno MD Werner Poewe MD Olivier Rascol MD PhD Kenneth Marek MD |
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| Affiliation: | 1. Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom;2. Boehringer Ingelheim GmbH, CD Medical Affairs CNS, Ingelheim, Germany;3. Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy;4. Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA;5. Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA;6. Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan;7. Department of Neurology, Innsbruck Medical University, Innsbruck, Austria;8. Departments of Clinical Pharmacology and Neurosciences, Clinical Investigation Center INSERM CIC9302 and INSERM UMR825, Toulouse University Hospital, Toulouse, France;9. Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA |
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| Abstract: | Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double‐blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed‐start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6–9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I–III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub‐study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients. © 2010 Movement Disorder Society |
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| Keywords: | Parkinson's disease pramipexole delayed‐start clinical trial neuroprotection |
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