A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia.
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Trenkwalder Claudia, Berg Daniela, Rascol Olivier, Eggert Karla, Ceballos-Baumann Andres, Corvol Jean-Christophe, Storch Alexander, Zhang Lin, Azulay Jean-Philippe, Broussolle Emmanuel, Defebvre Luc, Geny Christian, Gostkowski Michal, Stocchi Fabrizio, Tranchant Christine, Derkinderen Pascal, Durif Franck, Espay Alberto J, Feigin Andrew, Houeto Jean-Luc, Schwarz Johannes, Di Paolo Thérèse, Feuerbach Dominik, Hockey Hans-Ulrich, Jaeger Judith, Jakab Annamaria, Johns Donald, Linazasoro Gurutz, Maruff Paul, Rozenberg Izabela, Sovago Judit, Weiss Markus, Gomez-Mancilla Baltazar
Аннотация
METHODS: Patients with idiopathic Parkinson's disease and moderate to severe levodopa-induced dyskinesia were randomized to AQW051 10 mg (n = 24), AQW051 50 mg (n = 24), or placebo (n = 23) once daily for 28 days. Coprimary end points were change in Modified Abnormal Involuntary Movement Scale and Unified Parkinson's Disease Rating Scale part III scores. Secondary outcomes included pharmacokinetics.
RESULTS: In total, 67 patients completed the study. AQW051-treated patients experienced no significant improvements in Modified Abnormal Involuntary Movement Scale or Unified Parkinson's Disease Rating Scale part III scores by day 28. AQW051 was well tolerated; the most common adverse events were dyskinesia, fatigue, nausea, and falls.
CONCLUSIONS: AQW051 did not significantly reduce dyskinesia or parkinsonian severity. © 2016 International Parkinson and Movement Disorder Society.