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Influence of the Nonergot Dopamine Agonist Piribedil on Vigilance in Patients With Parkinson Disease and Excessive Daytime Sleepiness (PiViCog-PD): An 11-Week Randomized Comparison Trial Against Pramipexole and Ropinirole

Eggert, Karla MD*; Öhlwein, Christian MD; Kassubek, Jan MD; Wolz, Martin MD§; Kupsch, Andreas MD; Ceballos-Baumann, Andres MD; Ehret, Reinhard MD#; Polzer, Udo MD**; Klostermann, Fabian MD††; Schwarz, Johannes MD‡‡; Fuchs, Gerd MD§§; Jost, Wolfgang MD§§; Albert, Anita MSc*; Haag, Anja MSc*; Hermsen, Anke MSc*; Lohmüller, Karin∥∥; Kuhn, Katrin MD∥∥; Wangemann, Martina PhD∥∥; Oertel, Wolfgang H. MD*In Cooperation With the German Competence Network on Parkinson’s Disease

doi: 10.1097/WNF.0000000000000041
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Objectives The aim of this study was to investigate the effects of piribedil on vigilance and cognitive performance in patients with Parkinson disease experiencing excessive daytime sleepiness on pramipexole or ropinirole.

Methods In this 11-week randomized, active-controlled, rater-blinded phase III study, eligible patients were randomly assigned to either receive piribedil or to continue on pramipexole or ropinirole. The primary outcome was the median reaction times during the second 15 minutes of the subtest “vigilance” of the Test battery for Attention Performances (TAP). Secondary outcomes included the Epworth Sleepiness Scale, Unified Parkinson’s Disease Rating Scale, neuropsychological testing, and items of the Clinical Global Impression.

Results Forty-four patients received piribedil; 36 continued on either pramipexole or ropinirole. There was no difference in the primary end point reaction time of the TAP subtest vigilance between piribedil and the comparator (996 vs 954 milliseconds, P = 0.68). Piribedil reduced daytime sleepiness with lower Epworth Sleepiness Scale scores at the end of treatment compared with the comparator (−4 vs −2 points; P = 0.01). The median Unified Parkinson’s Disease Rating Scale III score at the end of treatment was comparable between the 2 groups. Neuropsychological tests revealed no significant between-treatment differences. A higher therapeutic effect and global improvement were shown by the Clinical Global Impression of piribedil-treated patients.

Conclusions This study shows that switching from pramipexole or ropinirole to piribedil has no effect on the reaction time of the TAP subtest vigilance but upholds the same therapeutic motor effect and reduces daytime sleepiness to a clinically relevant degree in patients with excessive daytime sleepiness.

*Department of Neurology, Philipps-University of Marburg, Marburg, Germany; †Gera, Germany; ‡Department of Neurology, University of Ulm, Ulm, Germany; §Department of Neurology, Elblandklinikum, Meissen, Germany; ∥Department of Neurology & Stereotactic Neurosurgery, Otto-von-Guericke-University, Magdeburg, Germany; ¶Department of Neurology, Schön Klinik München Schwabing and Technische Universität, München, Germany; #Neuro-Zentrum Steglitz, Berlin, Germany; ** Department of Neurology, Asklepios Fachklinikum, Stadtroda, Germany; ††Department of Neurology, CBF-Charité University Medicine, Berlin, Germany; ‡‡Department of Neurology, Klinik Haag, Haag Germany; §§Parkinson Klinik, Wolfach, Germany; and ∥∥Desitin Arzneimittel GmbH, Hamburg, Germany.

Address correspondence and reprint requests to Karla Eggert, MD, Department of Neurology, Philipps-Universität Marburg, Baldingerstraße, D-35043 Marburg, Germany; E-mail: eggert@med.uni-marburg.de

Conflicts of Interest and Source of Funding: Karla Eggert, Christian Öhlwein, Jan Kassubek, Martin Wolz, Andreas Kupsch, Andres Ceballos-Baumann, Reinhard Ehret, Udo Polzer, Fabian Klostermann, Johannes Schwarz, Gerd Fuchs, Wolfgang Jost, Anja Haag, and Wolfgang H. Oertel received consulting fees/honoraria and support for travel to meetings for the study. This study was supported by the Federal Ministry of Education and Research, German Competence Network on Parkinson’s Disease (01G19901, 01GI0201, 01GI0401) and by Desitin Arzneimittel GmbH (Germany). Wolfgang H. Oertel is Senior research Professor of the Charitable Hertie Foundation, Frankfurt/Main, Germany. No other funding was received for this work.

© 2014 by Lippincott Williams & Wilkins.