Double-blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease.
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.
Bronzova
Juliana
J
Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands. Juliana.Bronzova@solvay.com
Sampaio
Cristina
C
Hauser
Robert A
RA
Lang
Anthony E
AE
Rascol
Olivier
O
Theeuwes
Ad
A
van de Witte
Serge V
SV
van Scharrenburg
Guus
G
D000368:Aged; D001583:Benzoxazoles / Q000627:therapeutic use*; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020734:Parkinsonian Disorders / Q000188:drug therapy*; D010879:Piperazines / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D001583:Benzoxazoles; D018491:Dopamine Agonists; D010879:Piperazines; C480679:pardoprunox