title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: *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.
authors.forename: Karla
authors.initials: K
authors.lastname: Eggert
authors.forename: Christian
authors.initials: C
authors.lastname: Öhlwein
authors.forename: Jan
authors.initials: J
authors.lastname: Kassubek
authors.forename: Martin
authors.initials: M
authors.lastname: Wolz
authors.forename: Andreas
authors.initials: A
authors.lastname: Kupsch
authors.forename: Andres
authors.initials: A
authors.lastname: Ceballos-Baumann
authors.forename: Reinhard
authors.initials: R
authors.lastname: Ehret
authors.forename: Udo
authors.initials: U
authors.lastname: Polzer
authors.forename: Fabian
authors.initials: F
authors.lastname: Klostermann
authors.forename: Johannes
authors.initials: J
authors.lastname: Schwarz
authors.forename: Gerd
authors.initials: G
authors.lastname: Fuchs
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Jost
authors.forename: Anita
authors.initials: A
authors.lastname: Albert
authors.forename: Anja
authors.initials: A
authors.lastname: Haag
authors.forename: Anke
authors.initials: A
authors.lastname: Hermsen
authors.forename: Karin
authors.initials: K
authors.lastname: Lohmüller
authors.forename: Katrin
authors.initials: K
authors.lastname: Kuhn
authors.forename: Martina
authors.initials: M
authors.lastname: Wangemann
authors.forename: Wolfgang H
authors.initials: WH
authors.lastname: Oertel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000209:etiology*; D052160:Benzothiazoles; D006970:Disorders of Excessive Somnolence / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010300:Parkinson Disease / Q000150:complications* / Q000188:drug therapy*; D010891:Piribedil; D000077487:Pramipexole; D011930:Reaction Time / Q000187:drug effects; D012720:Severity of Illness Index
chemical_list: D000978:Antiparkinson Agents; D052160:Benzothiazoles; D007211:Indoles; C046649:ropinirole; D000077487:Pramipexole; D010891:Piribedil