Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease

Mov Disord. 2013 Jun;28(6):817-20. doi: 10.1002/mds.25395. Epub 2013 Apr 15.

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.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antiparkinson Agents / therapeutic use*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Humans
  • Longitudinal Studies
  • Middle Aged
  • Parkinson Disease / drug therapy*
  • Parkinson Disease / physiopathology
  • Pyrimidines / therapeutic use*
  • Severity of Illness Index
  • Triazoles / therapeutic use*

Substances

  • Antiparkinson Agents
  • Pyrimidines
  • Triazoles
  • 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