Funding agencies: The study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, New Jersey.
Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease
Article first published online: 15 APR 2013
Copyright © 2013 Movement Disorder Society
Volume 28, Issue 6, pages 817–820, June 2013
How to Cite
Factor, S. A., Wolski, K., Togasaki, D. M., Huyck, S., Cantillon, M., Ho, T.W., Hauser, R. A. and Pourcher, E. (2013), Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease. Mov. Disord., 28: 817–820. doi: 10.1002/mds.25395
Relevant conflicts of interest/financial disclosures: Stewart A. Factor has not received any remuneration in relation to preladenant from Schering-Plough or Merck & Co., Inc. Susan Huyck is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, New Jersey. Kenneth Wolski, T.W. Ho, and Marc Cantillon are former employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, New Jersey. Robert A. Hauser has received remuneration for consultative and advisory services related to preladenant. Emmanuelle Pourcher has received honoraria for consultancy related to preladenant.
Full financial disclosures and author roles may be found in the online version of this article.
- Issue published online: 25 JUN 2013
- Article first published online: 15 APR 2013
- Manuscript Accepted: 15 JAN 2013
- Manuscript Revised: 10 JAN 2013
- Manuscript Received: 19 OCT 2012
- adenosine A2A receptor antagonist;
- Parkinson's disease;
- OFF time;
- clinical trial
Preladenant is a selective adenosine A2A receptor antagonist under investigation for Parkinson's disease treatment.
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.
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.
Long-term preladenant treatment (5 mg twice a day) was generally well tolerated and provided sustained OFF time reductions and ON time increases. © 2013 Movement Disorder Society