Table of Contents Author Guidelines Submit a Manuscript
Parkinson’s Disease
Volume 2014, Article ID 158353, 7 pages
http://dx.doi.org/10.1155/2014/158353
Clinical Study

Are Branded and Generic Extended-Release Ropinirole Formulations Equally Efficacious? A Rater-Blinded, Switch-Over, Multicenter Study

1Department of Neurology, University of Pécs, Rét Utca 2, Pécs 7623, Hungary
2Department of Neurology, Kaposi Mór County Hospital, Tallián Gyula Utca 20-32, Kaposvár 7400, Hungary
3MTA-PTE Clinical Neuroscience MR Research Group, Rét Utca 2, Pécs 7623, Hungary
4Department of Neurology, Health Center of City of Pécs, Dr. Veress Endre Utca 2, Pécs 7633, Hungary
5Institute of Behavioral Sciences, University of Pécs, Szigeti Utca 12, Pécs 7624, Hungary
6Department of Neurosurgery, University of Pécs, Rét Utca 2, Pécs 7623, Hungary

Received 16 May 2014; Revised 29 July 2014; Accepted 29 July 2014; Published 26 August 2014

Academic Editor: Jan O. Aasly

Copyright © 2014 Edit Bosnyák et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The aim of this study was to compare the efficacy of the branded and a generic extended-release ropinirole formulation in the treatment of advanced Parkinson’s disease (PD). Of 22 enrolled patients 21 completed the study. A rater blinded to treatment evaluated Unified Parkinson’s Disease Rating Scale, Fahn-Tolosa-Marin Tremor Rating Scale, Nonmotor Symptoms Assessment Scale, and a structured questionnaire on ropinirole side effects. Besides, the patients self-administered EQ-5D, Parkinson’s Disease Sleep Scale (PDSS-2), and Beck Depression Inventories. Branded and generic ropinirole treatment achieved similar scores on all tests measuring severity of motor symptoms (primary endpoint, UPDRS-III: 27.0 versus 28.0 points, ). Based on patient diaries, the lengths of “good time periods” were comparable (10.5 and 10.0 hours for branded and generic ropinirole, resp., ). However, generic ropinirole therapy achieved almost 3.0 hours shorter on time without dyskinesia (6.5 versus. 9.5 hours, ) and 2.5 hours longer on time with slight dyskinesia (3.5 versus. 1.0 hours, ) than the branded ropinirole did. Except for gastrointestinal problems, nonmotor symptoms were similarly controlled. Patients did not prefer either formulation. Although this study has to be interpreted with limitations, it demonstrated that both generic and branded ropinirole administration can achieve similar control on most symptoms of PD.