Journal
MOVEMENT DISORDERS
Volume 25, Issue 6, Pages 738-746Publisher
WILEY-BLACKWELL
DOI: 10.1002/mds.22948
Keywords
Parkinson's disease; partial dopamine agonist; monotherapy; pardoprunox; randomized controlled clinical trial
Categories
Funding
- Solvay Pharmaceuticals
- Astellas
- Brane
- Eisai
- Fujisawa
- Gruenthal
- Kyowa
- Lundbeck
- Neurobiotech
- Newron
- Novartis
- Schering-Plough
- Serono
- Servier
- Solvay
- UCB
- Xytis
- Boehriner-Ingelheim
- Ceregene
- GlaxoSmithKline
- Medtronic
- Prestwick
- Teva
- Valeant
- Schering
- Teva Neuroscience
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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. (C) 2010 Movement Disorder Society
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