title: Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease.
abstract: BACKGROUND
  Preladenant is a selective adenosine A₂A receptor antagonist under investigation for Parkinson's disease treatment.
  
  
  METHODS
  A phase 2 36-week open-label follow-up of a double-blind study using preladenant 5 mg twice a day as a levodopa adjunct in 140 subjects with fluctuating Parkinson's disease was conducted. The primary end point was adverse event (AE) assessment. Secondary (efficacy) analyses included hours/day spent in OFF and ON states and dyskinesia prevalence/severity.
  
  
  RESULTS
  The 36-week open-label phase was completed by 106 of 140 subjects (76%). AE-related treatment discontinuations occurred in 19 subjects (14%). Treatment-emergent AEs, reported by ≥15% of subjects, were dyskinesia (33%) and constipation (19%). Preladenant 5 mg twice a day provided OFF time reductions (1.4-1.9 hours/day) and ON time increases (1.2-1.5 hours/day) throughout the 36-week treatment relative to the baseline of the double-blind study.
  
  
  CONCLUSIONS
  Long-term preladenant treatment (5 mg twice a day) was generally well tolerated and provided sustained OFF time reductions and ON time increases.
authors.affiliation: Emory University School of Medicine, Department of Neurology, Atlanta, Georgia 30329, USA. sfactor@emory.edu
authors.forename: Stewart A
authors.initials: SA
authors.lastname: Factor
authors.forename: Kenneth
authors.initials: K
authors.lastname: Wolski
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Togasaki
authors.forename: Susan
authors.initials: S
authors.lastname: Huyck
authors.forename: Marc
authors.initials: M
authors.lastname: Cantillon
authors.forename: T W
authors.initials: TW
authors.lastname: Ho
authors.forename: Robert A
authors.initials: RA
authors.lastname: Hauser
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Pourcher
mesh_terms: D000368:Aged; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology; D011743:Pyrimidines / Q000627:therapeutic use*; D012720:Severity of Illness Index; D014230:Triazoles / Q000627:therapeutic use*
chemical_list: D000978:Antiparkinson Agents; D011743:Pyrimidines; D014230:Triazoles; C539997:2-(2-furanyl)-7-(2-(4-(4-(2-methoxyethoxy)phenyl)-1-piperazinyl)ethyl)-7H-pyrazolo(4,3-e)(1,2,4)triazolo(1,5-c)pyrimidine-5-amine