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

Authors


  • Funding agencies: The study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, New Jersey.

  • 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.

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. © 2013 Movement Disorder Society

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