Double-blind study of pardoprunox, a new partial dopamine agonist, in early
Parkinson's disease.
Author(s): Bronzova J, Sampaio C, Hauser RA, Lang AE, Rascol O, Theeuwes A, van de Witte SV,
van Scharrenburg G; Bruegel Study Group.
Collaborators: Milanov I, Shotekov P, Polivka J, Dolezil D, Jolma T, Soininen H,
Bhatt M, Borgohain R, Obelieniene D, Pruchnik-Wolinska D, Tutaj A, Bogucki A,
Hasiec T, Avakyan G, Fedorova N, Illarioshkin S, Skoromets A, Golubev V, Odinak
M, Stoliarov I, Bitenskyy V, Dubenko Y, Karaban I, Mishchenko T, Moskovko S.
Affiliation(s): Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The
Netherlands. Juliana.Bronzova@solvay.com
Publication date & source: 2010, Mov Disord. , 25(6):738-46
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.
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