Double-blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease.

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 (> or = 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 > or = 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.

• Authors: Juliana Bronzova, Cristina Sampaio, Robert A Hauser, Anthony E Lang, Olivier Rascol, Ad Theeuwes, Serge V van de Witte, Guus van Scharrenburg, Bruegel Study Group
• Journal: Movement disorders : official journal of the Movement Disorder Society (Mov Disord) Vol. 25 Issue 6 Pg. 738-46 (Apr 30 2010) ISSN: 1531-8257 [Electronic] United States
• PMID: 20198713 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: 2010 Movement Disorder Society

Chemical References

• Benzoxazoles
• Dopamine Agonists
• Piperazines
• pardoprunox

Topics

• Aged
• Benzoxazoles (therapeutic use)
• Dopamine Agonists (therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Parkinsonian Disorders (drug therapy)
• Piperazines (therapeutic use)
• Severity of Illness Index
• Treatment Outcome