Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease
作者： Stewart A Factor , Kenneth Wolski , Daniel M Togasaki , Susan Huyck , Marc Cantillon
DOI: 10.1002/MDS.25395
关键词:
摘要: 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 double-blind study using preladenant 5 mg twice day as levodopa adjunct in 140 subjects with fluctuating was conducted. The primary end point adverse event (AE) assessment. Secondary (efficacy) analyses included hours/day spent OFF and ON states dyskinesia prevalence/severity. Results The completed by 106 (76%). AE-related treatment discontinuations occurred 19 (14%). Treatment-emergent AEs, reported ≥15% subjects, were (33%) constipation (19%). Preladenant provided time reductions (1.4–1.9 hours/day) increases (1.2–1.5 throughout the relative to baseline study. Conclusions Long-term (5 day) generally well tolerated sustained increases. © 2013 Movement Disorder Society
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