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Original Paper

Safety and Tolerability of Pardoprunox, a New Partial Dopamine Agonist, in a Randomized, Controlled Study of Patients with Advanced Parkinson’s Disease

Hauser R.A.a · Bronzova J.b · Sampaio C.c · Lang A.E.d · Rascol O.e · Theeuwes A.b · van de Witte S.V.b

Author affiliations

aUniversity of South Florida, Tampa, Fla., USA; bSolvay Pharmaceuticals B.V., Weesp, The Netherlands; cLaboratório de Farmacologia Clinica e Terapêutica e Instituto de Medicina Molecular, Faculdade de Medicina de Lisboa, Lisboa, Portugal; dToronto Western Hospital, University of Toronto, Toronto, Ont., Canada; eUniversity Hospital of Toulouse, Clinical Investigation Center, Departments of Neurosciences and Clinical Pharmacology, INSERM UMR 825, Toulouse, France

Related Articles for ""

Eur Neurol 2009;62:40–48

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: October 13, 2008
Accepted: February 09, 2009
Published online: April 30, 2009
Issue release date: June 2009

Number of Print Pages: 9
Number of Figures: 4
Number of Tables: 5

ISSN: 0014-3022 (Print)
eISSN: 1421-9913 (Online)

For additional information: https://www.karger.com/ENE

Abstract

Aims: To investigate the safety and tolerability of pardoprunox (SLV308), a novel partial dopamine agonist, as an adjunct to levodopa in patients with advanced Parkinson’s disease, using two titration schedules. Methods: Patients were randomized to pardoprunox (n = 51) or placebo (n = 11). Pardoprunox was titrated to the highest tolerated dose (range, 0.3–42 mg/day) over 7 weeks, using a gradual dose escalation without intermediate steps (group 1) or with intermediate steps (group 2). Results: The cumulative drop-out rate was greater in group 1 (without intermediate steps, 56.0%) than in group 2 (with intermediate steps, 34.6%), or with placebo (9.1%). In group 2, doses up to 18 mg/day were well tolerated with a cumulative drop-out rate of 7.7% (2/26) and a drop-out rate due to adverse events of 4.0% (1/26). The most common adverse events reported were nausea, vomiting, headache, and dizziness. There was a trend for reduced OFF time (p = 0.054) in the combined pardoprunox group compared to placebo. Conclusions: The pardoprunox safety and tolerability profile as an adjunct to levodopa was improved using a gradual titration schedule that included intermediate dose steps. Using this titration, doses up to 18 mg/day were well tolerated.

© 2009 S. Karger AG, Basel


References

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: October 13, 2008
Accepted: February 09, 2009
Published online: April 30, 2009
Issue release date: June 2009

Number of Print Pages: 9
Number of Figures: 4
Number of Tables: 5

ISSN: 0014-3022 (Print)
eISSN: 1421-9913 (Online)

For additional information: https://www.karger.com/ENE


Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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