Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease
| Autor: | Tony W. Ho, Susan Huyck, Marc Cantillon, Emmanuelle Pourcher, Daniel M. Togasaki, Stewart A. Factor, Kenneth Wolski, Robert A. Hauser |
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| Rok vydání: | 2013 |
| Předmět: |
Levodopa
Parkinson's disease business.industry medicine.disease law.invention chemistry.chemical_compound Preladenant Neurology Dyskinesia Randomized controlled trial chemistry law Anesthesia Severity of illness medicine Clinical endpoint Neurology (clinical) medicine.symptom Adverse effect business medicine.drug |
| Zdroj: | Movement Disorders. 28:817-820 |
| ISSN: | 0885-3185 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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