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

Stewart A. Factor, Kenneth Wolski, Daniel M. Togasaki, Susan Huyck, Marc Cantillon, T. W. Ho, Robert A. Hauser, Emmanuelle Pourcher

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)817-820
Number of pages4
JournalMovement Disorders
Volume28
Issue number6
DOIs
StatePublished - Jun 1 2013

Keywords

  • Adenosine A receptor antagonist
  • Clinical trial
  • Fluctuations
  • OFF time
  • Parkinson's disease

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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